System and method for delivering a left atrial appendage containment device

ABSTRACT

A method of delivering and deploying the device for containing the emboli during a surgical procedure proximate to the heart. Access is gained to the heart and the left atrium such that a distal end of the delivery sheath can be located near the left atrial appendage. A distal end of a delivery catheter can be loaded with the device in a collapsed position and passed through the delivery sheath thereby delivering the device within the left atrial appendage. The device is expanded to contain emboli in the left atrium appendage.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/003,696, filed Dec. 3, 2004, now abandoned, which claims the prioritybenefit under 35 U.S.C. .sctn. 119(e) of the provisional application60/526,960, filed Dec. 4, 2003, each of which is hereby incorporated byreference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Embodiments of this invention relate in general to a system and methodfor delivering a left atrial appendage containment device.

2. Description of the Related Art

Embolic stroke is the nation's third leading killer for adults, and is amajor cause of disability. There are over 700,000 strokes per year inthe United States alone. Of these, roughly 100,000 are hemorrhagic, and600,000 are ischemic (either due to vessel narrowing or to embolism).The most common cause of embolic stroke emanating from the heart isthrombus formation due to atrial fibrillation. Approximately 80,000strokes per year are attributable to atrial fibrillation. Atrialfibrillation is an arrhythmia of the heart that results in a rapid andchaotic heartbeat that produces lower cardiac output and irregular andturbulent blood flow in the vascular system. There are over five millionpeople worldwide with atrial fibrillation, with about four hundredthousand new cases reported each year. Atrial fibrillation is associatedwith a 500 percent greater risk of stroke due to the condition. Apatient with atrial fibrillation typically has a significantly decreasedquality of life due, in part, to the fear of a stroke, and thepharmaceutical regimen necessary to reduce that risk.

For patients who develop atrial thrombus from atrial fibrillation, theclot normally occurs in the left atrial appendage (LAA) of the heart.The LAA is a cavity which looks like a small finger or windsock andwhich is connected to the lateral wall of the left atrium between themitral valve and the root of the left pulmonary vein. The LAA normallycontracts with the rest of the left atrium during a normal heart cycle,thus keeping blood from becoming stagnant therein, but often fails tocontract with any vigor in patients experiencing atrial fibrillation dueto the discoordinate electrical signals associated with AF. As a result,thrombus formation is predisposed to form in the stagnant blood withinthe LAA.

Blackshear and Odell have reported that of the 1288 patients withnon-rheumatic atrial fibrillation involved in their study, 221 (17%) hadthrombus detected in the left atrium of the heart. Blackshear J L, OdellJ A., Appendage Obliteration to Reduce Stroke in Cardiac SurgicalPatients With Atrial Fibrillation. Ann Thorac. Surg., 1996.61(2):755-9.Of the patients with atrial thrombus, 201 (91%) had the atrial thrombuslocated within the left atrial appendage. The foregoing suggests thatthe elimination or containment of thrombus formed within the LAA ofpatients with atrial fibrillation would significantly reduce theincidence of stroke in those patients.

Pharmacological therapies for stroke prevention such as oral or systemicadministration of warfarin or the like have been inadequate due toserious side effects of the medications and lack of patient compliancein taking the medication. Invasive surgical or thorascopic techniqueshave been used to obliterate the LAA, however, many patients are notsuitable candidates for such surgical procedures due to a compromisedcondition or having previously undergone cardiac surgery. In addition,the perceived risks of even a thorascopic surgical procedure oftenoutweigh the potential benefits. See Blackshear and Odell, above. Seealso Lindsay B D., Obliteration of the Left Atrial Appendage: A ConceptWorth Testing, Ann Thorac. Surg., 1996.61(2):515.

During surgical procedures, such as mitral valve repair, thrombus in theleft atrial appendage may leave the LAA and enter the blood stream of apatient. The thrombus in the blood stream of the patient can causeembolic stroke. There are known techniques for closing off the LAA sothat thrombus cannot enter the patient's blood stream. For example,surgeons have used staples or sutures to close the orifice of the LAA,such that the closed off LAA surrounds the thrombus. Unfortunately,using staples or sutures to close off the LAA may not completely closethe orifice of the LAA. Thus, thrombus may leave the LAA and enter thepatient's blood stream, even though the LAA is closed with staples orsutures. Additionally, closing the orifice of the LAA by using staplesor sutures may result in discontinuities, such as folds or creases, inthe endocardial surface facing the left atrium. Unfortunately, bloodclots may form in these discontinuities and can enter the patient'sblood stream, thereby causing health problems. Moreover, it is difficultto place sutures at the orifice of the LAA and may result in a residualappendage. For example, an epicardial approach to ligate sutures canresult in a residual appendage. Similarly, thrombus may form in theresidual appendage and enter the patient's blood stream causing healthproblems.

Despite the various efforts in the prior art, there remains a need for aminimally invasive method and associated devices for reducing the riskof health problems (e.g., embolic stroke) related to thrombus located inthe left atrial appendage.

SUMMARY OF THE INVENTION

There is provided in accordance with one embodiment of the presentinvention a method for containing emboli within a left atrial appendageof a patient. In one embodiment, an implant that has a frame that isexpandable from a reduced cross section to an enlarged cross section isprovided, the frame extending between a proximal hub and a distal hub.The frame is releasably coupled near its proximal hub to a control lineextending proximally away from the proximal hub. A slider assembly isprovided that is connected to the frame, the slider assembly comprisinga guide tube extending proximally from the distal hub and an innermember slideably received within the guide tube, the inner member beingreleasably coupled to an elongate core that extends proximally throughthe proximal hub, wherein movement of the inner member relative to theframe is at least partially limited by interference between a portion ofthe inner member and a portion of the guide tube.

In one embodiment, a method provides a left atrium access path to theleft atrial appendage for delivery of a device, such as the implantdiscussed above. However, it will be appreciated that any suitabledevice may be used. A delivery sheath having a distal end can bedistally advanced along the left atrium access path. The distal end ofthe delivery sheath is distally advanced until the delivery sheath islocated proximate to an orifice of the left atrial appendage. The methodprovides a delivery catheter having a distal end that is coupled to theimplant. The distal end of the delivery catheter that is coupled theimplant is distally advanced through the delivery sheath along the leftatrium access path and the implant is delivered to the left atrialappendage of the patient. The frame of the implant is expanded withinthe left atrial appendage by providing relative movement between thecontrol line and the elongated core, wherein the elongated core ismoveable relative to the implant while coupled to the inner member whenthe frame is positioned within the left atrial appendage.

In one embodiment, the delivery sheath is moved along the left atriumaccess path, which is located within a pulmonary vein, until the distalend of the delivery sheath is located near the LAA of the heart.

In another embodiment, the delivery sheath is moved along the leftatrium access path, which is located through a hole in a wall of theleft atrium, until the distal end of the delivery sheath is located nearthe LAA of the heart.

In another embodiment, a transseptal hole is provided and the deliverysheath is moved along the left atrium path, which is located within theright atrium and through the transseptal hole, until the distal end ofthe delivery sheath is located near the LAA of the heart.

In another embodiment, the left atrium is accessed by a surgical heartprocedure. The delivery sheath is moved along the left atrium accesspath, which is located through the opening in the heart, until thedistal end of the delivery sheath is located near the LAA of the heart.

In another embodiment, the left atrium is accessed by surgical heartprocedure. The implant can be distally advanced along the left atriumaccess path, and the implant can be manually delivered to the leftatrial appendage of the patient.

Further, in one preferred embodiment, a user is provided with a locationof the distal end of the distally advanced delivery sheath within theleft atrium of the patient by using direct visualization in the form ofexamination of the exterior surface of the heart, visualization throughthe use of echocardiography, visualization through optics includingthrough thoracoscopes, or the use of X-ray fluoroscopy.

In another embodiment, a method of delivering a containment device to aleft atrial appendage of a patient is provided. The method includesproviding a left atrium access path and a delivery sheath is locatedalong the left atrium access path. The delivery sheath has both adelivery path and a distal end. The delivery path extends along andwithin the delivery sheath. The delivery sheath is moved to place thedistal end of the delivery sheath within the LAA of a heart. An implantis passed within the delivery sheath in a distal direction to the distalend of the delivery sheath. The implant is deployed by expanding a framethat is expandable from a reduced cross section to an enlarged crosssection. In one embodiment, the implant contacts a surface of the LAA ofthe heart and forms a seal between the implant and the surface of theLAA.

It will be appreciated that any suitable device or instrument may bedelivered to the LAA along the left atrium access path. In oneembodiment, a device is delivered to the LAA as an adjunct to a surgicalheart procedure (e.g., during mitral valve repair).

In some embodiments, a method is provide for delivering a device to aleft atrial appendage. The method comprises forming an opening in achest of a patient suitable for surgical heart procedures. Animplantable device is advanced through the opening and into a leftatrium. The implantable device is passed through the left atrium and ispositioned at the left atrial appendage.

In some embodiments, a method is provided for delivering a device to aleft atrial appendage. The method comprises forming an aperture in theouter wall of a left atrium of a heart. A delivery sheath is advancedthrough the aperture and into the left atrium. A distal end of thedelivery sheath is positioned proximate to an orifice of the left atrialappendage while the delivery sheath extends through the left atrium andthe aperture. A device is advanced through the delivery sheath and outof the distal end. The device is implanted at the left atrial appendage.

In some embodiments, a method is provided for delivering a device to aleft atrial appendage. The method comprises providing a delivery sheathhaving a lumen and a distal end and a transition catheter having a tipconfigured to reduce injury to a patient. The delivery sheath andtransition catheter are advanced along the right atrium and through atransseptal hole and into the left atrium until a distal end of thedelivery sheath is proximate to an orifice of a left atrial appendage.The transition catheter is removed from the delivery sheath. The deviceis distally advanced a through the delivery sheath. The device isimplanted at the left atrial appendage while the distal end of thedelivery sheath is disposed within the left atrial appendage.

In some embodiments, a method is provided for delivering a device to aleft atrial appendage. The method comprises providing a left atriumaccess path through a pulmonary vein to a left atrial appendage. Adelivery sheath is advanced along the left atrium access path until thedelivery sheath is located proximate to the left atrial appendage. Animplant is advanced through the delivery sheath until the implant passesout of a distal end of the delivery sheath. The device is implanted atthe left atrial appendage.

In some embodiments, a system for delivering a device to the left atrialappendage comprises an implant sized and configured to prevent passageof embolic material from a left atrial appendage. A delivery sheathdefines a lumen and a distal end. A transition catheter has anatraumatic tip and is configured to slide through the lumen of thedelivery sheath. The transition catheter is adapted to extend from thedistal end of the delivery sheath when the distal end is proximate tothe left atrial appendage. A delivery catheter is removably coupled tothe implant. The delivery catheter and implant are configured to passthrough the lumen of the delivery sheath to the left atrial appendage.

In some embodiments, a system for delivering a device to the left atrialappendage comprises an implant sized and configured to prevent passageof embolic material from a left atrial appendage. A delivery device isconfigured to carry the implant to the left atrial appendage. Thedelivery device has a length configured to access the left atrialappendage through an opening in a chest of a patient. The deliverydevice has a length of about 80 cm or less.

In some embodiments, a system for delivering a device into the leftatrial appendage comprises an implant sized and configured to preventpassage of embolic material from a left atrial appendage. A deliverydevice is configured to carry the implant to the left atrial appendage.The delivery device has a length configured to access the left atrialappendage through an opening in a chest of a patient. The system furthercomprises means for providing surgical access to the left atrialappendage through the chest of the patient.

In some embodiments, a system for delivering a device into the leftatrial appendage of a patient comprises an implant sized and configuredto prevent passage of embolic material from a left atrial appendage. Adelivery device is configured to carry the implant to the left atrialappendage. The delivery device has a length configured to access theleft atrial appendage through an opening in a chest of a patient. Thesystem further comprises a means for performing a surgical heartprocedure in the heart of the patient.

In some embodiments, a system for delivering a device to the left atrialappendage comprises an implant sized and configured to prevent passageof embolic material from a left atrial appendage. A delivery device isconfigured to carry the implant to the left atrial appendage. Thedelivery device is sized and configured to access the left atrialappendage through a pulmonary vein. The delivery device has a length ofabout 50 cm or less.

In some, embodiments, a kit can be provided suitable for delivering adevice to the left atrial appendage. For example, the kit can comprisethe devices, apparatuses, and/or systems described herein. The kit mayoptionally comprise packaging configured to receive a system configuredto deliver a device to the left atrial appendage and/or instructions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a containment device in accordance withone embodiment of the present invention;

FIG. 2 is a side elevational view of the containment device shown inFIG. 1;

FIG. 3 is a perspective view of a containment device in accordance withan alternate embodiment of the present invention;

FIG. 4 is a side elevational view of the embodiment shown in FIG. 3;

FIG. 5 is a perspective view of a containment device in accordance witha further embodiment of the present invention;

FIG. 6 is a side elevational view of the embodiment of FIG. 5;

FIG. 7 is a perspective view of a support structure for a containmentdevice in accordance with a further embodiment of the present invention;

FIG. 7A is a side elevational view of the device of FIG. 7;

FIG. 7B is an end view taken along the line 7B-7B of FIG. 7A;

FIG. 8 is a schematic illustration of an inflatable balloon positionedwithin the containment device of FIG. 7;

FIG. 9 is a schematic view of a pull string deployment embodiment of thecontainment device of FIG. 7;

FIGS. 10 and 11 are side elevational schematic representations ofpartial and complete barrier layers on the containment device of FIG. 7;

FIG. 12 is a side elevational schematic view of an alternate containmentdevice in accordance with another embodiment of the present invention;

FIG. 13 is a schematic view of a bonding layer mesh for use in forming acomposite barrier membrane in accordance with an embodiment of thepresent invention;

FIG. 14 is an exploded cross sectional view of the components of acomposite barrier member in accordance with an embodiment of the presentinvention;

FIG. 15 is a cross sectional view through a composite barrier formedfrom the components illustrated in FIG. 14;

FIG. 16 is a top plan view of the composite barrier illustrated in FIG.15;

FIG. 17 is a schematic view of a deployment system in accordance withone embodiment of the present invention;

FIG. 17A is an enlarged view of the deployment system of FIG. 17,showing a releasable lock in an engaged configuration;

FIG. 17B is an enlarged view as in FIG. 17A, with a core axiallyretracted to release the implant;

FIG. 18 is a perspective view of a flexible guide tube for use in theconfigurations of FIG. 17 and/or FIG. 19;

FIG. 19 is a schematic view of an alternate deployment system inaccordance with one embodiment of the present invention;

FIGS. 19A-19B illustrate a removal sequence for an implanted device inaccordance with one embodiment of the present invention;

FIG. 20 is a schematic cross sectional view through the distal end of aretrieval catheter having a containment device removably connectedthereto;

FIG. 20A is a schematic cross sectional view of the system illustratedin FIG. 20, with the containment device axially elongated and radiallyreduced;

FIG. 20B is a cross sectional schematic view as in FIG. 20A, with thecontainment device drawn part way into the delivery catheter;

FIG. 20C is a schematic view as in FIG. 20B, with the containment deviceand delivery catheter drawn into a delivery sheath;

FIG. 21 is a schematic cross sectional view of a distal portion of anadjustable implant deployment system;

FIG. 21A is a schematic cross sectional view of a slider assembly foruse with the adjustable implant deployment system of FIG. 21;

FIG. 21B is a cross sectional view of the slider assembly of FIG. 21Ataken along cut line 21B-21B;

FIG. 21C is a perspective view of the slider assembly of FIG. 21 showncoupled to an axially moveable core;

FIG. 21D is a partial cut away view of the slider assembly of FIG. 21Cshowing the position of the axially moveable core with respect to theslider nut of the slider assembly;

FIG. 21E is a partial cut away view of the slider assembly of FIG. 21shown coupled to the frame of a detachable implant;

FIG. 22 is a schematic cross sectional view of a distal portion ofanother embodiment of an adjustable implant deployment system;

FIG. 22A is a schematic cross sectional view of a slider assembly foruse with the adjustable implant deployment system of FIG. 22;

FIG. 23 is a schematic cross sectional view of another embodiment of aslider assembly;

FIGS. 24 and 25 are alternative cross sectional views taken along cutline A-A of FIG. 23;

FIG. 26 is a schematic cross sectional view of another slider assemblyfor use with the adjustable implant deployment system of FIG. 21;

FIG. 26A is a schematic cross sectional view of another slider assemblyfor use with the adjustable implant deployment system of FIG. 21;

FIG. 27 is a cross sectional view taken along cut line 27-27 of FIG. 26;

FIG. 28 is a schematic cross sectional view of a slider assemblyincorporating quick-disconnect functionality;

FIG. 29 is a schematic cross sectional view of another slider assemblyincorporating quick-disconnect functionality, constructed in accordancewith another embodiment of the present invention;

FIG. 29A is a side elevational view of a bayonet mount coupling theguide tube of the slider assembly of an implant to an axial moveablecore, in accordance with one embodiment of the present invention;

FIG. 29B is a side elevational view of the axially moveable core of FIG.29A;

FIG. 29C is an end view of the axially moveable core of FIG. 29A;

FIG. 29D is an end view of the guide tube of the slider assembly of theimplant of FIG. 29A;

FIG. 29E is a side elevational view of one embodiment of a maze-typeslotted guide tube in accordance with one embodiment of the presentinvention;

FIG. 29F is a side elevational view of another embodiment of a maze-typeslotted guide tube in accordance with one embodiment of the presentinvention;

FIG. 29G is an end view of an axially moveable core in accordance withanother embodiment of the present invention;

FIG. 29H is one embodiment of a key mount coupling a first and secondportion of an axially moveable core in accordance with one embodiment ofthe present invention;

FIG. 29I is a schematic cross sectional view of the key mount of FIG.29H taken along cut line 29I-291;

FIG. 30 is a schematic view of a deployment system delivering animplantable containment device to the left atrial appendage;

FIG. 31 is a schematic cross sectional view of an implantablecontainment device built in accordance with one embodiment of thepresent invention;

FIG. 32 is a schematic view of a delivery system constructed inaccordance with one embodiment of the present invention;

FIG. 32A is a cross sectional view of a deployment catheter as shown inFIG. 32, taken along cut line 32A-32A.

FIG. 33 is a schematic view of the delivery system of FIG. 32, shownattached to an implantable containment device;

FIGS. 34A and 34B are a schematic cross sectional view and an end view,respectively, of a loading collar used in the system of FIG. 32;

FIG. 35 is a schematic view of a recapture sheath used in the system ofFIG. 32;

FIG. 36 is an enlarged partial cross sectional view of the deploymentsystem of FIG. 32;

FIG. 37 is a partial cross sectional view of an axially moveable coreused in the system of FIG. 32;

FIG. 37A is a cross sectional view of the axially moveable core of FIG.37 taken along cut line 37A-37A;

FIGS. 38A-C are a schematic view of a delivery sheath used incombination with the system of FIG. 32;

FIG. 39 is a schematic view of a delivery sheath and a transitioncatheter used in combination with the system of FIG. 32;

FIG. 40 is a view of a heart and a delivery sheath located along thepulmonary vein;

FIG. 41 is a view of a heart and a delivery sheath through an opening ofthe left atrium;

FIG. 41A is a view of an open heart and a delivery path;

FIG. 42 is a view of the heart and a delivery sheath located within theright atrium and passing through a transseptal puncture;

FIG. 43 a schematic view of a delivery system attached to an implantablecontainment device in accordance with another embodiment;

FIG. 44 is a cross sectional view of a deployment catheter as shown inFIG. 43, taken along cut line 44-44;

FIG. 45 a schematic view of a delivery system attached to an implantablecontainment device in accordance with another embodiment;

FIG. 46 is a partial cross-sectional schematic view of a delivery systemattached to an implantable containment device in accordance with anotherembodiment; and

FIG. 47 is a schematic view of the delivery system shown in FIG. 46.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1 and 2, there is illustrated one embodiment of anocclusion or containment device 10 in accordance with the presentinvention. Although the present invention will be described primarily inthe context of an occlusion device, the present inventors alsocontemplate omitting the fabric cover or enlarging the pore size toproduce implantable filters or other devices which are enlargeable at aremote implantation site. The terms “occlusion device” or “containmentdevice” are intended to encompass all such devices.

The occlusion device 10 comprises an occluding member 11 comprising aframe 14 and a barrier 15. In the illustrated embodiment, the frame 14comprises a plurality of radially outwardly extending spokes 17 eachhaving a length within the range of from about 0.5 cm to about 2 cm froma hub 16. In one embodiment, the spokes have an axial length of about1.5 cm. Depending upon the desired introduction crossing profile of thecollapsed occlusion device 10, as well as structural strengthrequirements in the deployed device, anywhere within the range of fromabout 3 spokes to about 40 spokes may be utilized. In some embodiments,anywhere from about 12 to about 24 spokes are utilized, and, 18 spokesare utilized in one embodiment.

The spokes are advanceable from a generally axially extendingorientation such as to fit within a tubular introduction catheter to aradially inclined orientation as illustrated in FIG. 1 and FIG. 2following deployment from the catheter. In a self-expandable embodiment,the spokes are biased radially outwardly such that the occlusion memberexpands to its enlarged, implantation cross-section under its own biasfollowing deployment from the catheter. Alternatively, the occlusionmember may be enlarged using any of a variety of enlargement structuressuch as an inflatable balloon, or a catheter for axially shortening theocclusion member, as is discussed further below.

Preferably, the spokes comprise a metal such as stainless steel,nitinol, Elgiloy, or others which can be determined through routineexperimentation by those of skill in the art.

Wires having a circular or rectangular cross-section may be utilizeddepending upon the manufacturing technique. In one embodiment,rectangular cross section spokes are cut such as by known laser cuttingtechniques from tube stock, a portion of which forms the hub 16.

The barrier 15 may comprise any of a variety of materials whichfacilitate cellular in-growth, such as ePTFE. The suitability ofalternate materials for barrier 15 can be determined through routineexperimentation by those of skill in the art. The barrier 15 may beprovided on either one or both axially facing sides of the occlusionmember. In one embodiment, the barrier 15 comprises two layers, with onelayer on each side of the frame 14. The two layers may be bonded to eachother around the spokes 17 in any of a variety of ways, such as by heatbonding with or without an intermediate bonding layer such aspolyethylene or FEP, adhesives, sutures, and other techniques which willbe apparent to those of skill in the art in view of the disclosureherein. The barrier 15 preferably has a thickness of no more than about0.006″ and a porosity within the range of from about 5 .mu.m to about 60.mu.m.

The barrier 15 in one embodiment preferably is securely attached to theframe 14 and retains a sufficient porosity to facilitate cellularingrowth and/or attachment. One method of manufacturing a suitablecomposite membrane barrier 15 is illustrated in FIGS. 13-16. Asillustrated schematically in FIG. 13, a bonding layer 254 preferablycomprises a mesh or other porous structure having an open surface areawithin the range of from about 10% to about 90%. Preferably, the opensurface area of the mesh is within the range of from about 30% to about60%. The opening or pore size of the bonding layer 254 is preferablywithin the range of from about 0.005 inches to about 0.050 inches, and,in one embodiment, is about 0.020 inches. The thickness of the bondinglayer 254 can be varied widely, and is generally within the range offrom about 0.0005 inches to about 0.005 inches. In a preferredembodiment, the bonding layer 254 has a thickness of about 0.001 toabout 0.002 inches. One suitable polyethylene bonding mesh is availablefrom Smith and Nephew, under the code SN9.

Referring to FIG. 14, the bonding layer 254 is preferably placedadjacent one or both sides of a spoke or other frame element 14. Thebonding layer 254 and frame 14 layers are then positioned in-between afirst membrane 250 and a second membrane 252 to provide a compositemembrane stack. The first membrane 250 and second membrane 252 maycomprise any of a variety of materials and thicknesses, depending uponthe desired functional result. Generally, the membrane has a thicknesswithin the range of from about 0.0005 inches to about 0.010 inches. Inone embodiment, the membranes 250 and 252 each have a thickness on theorder of from about 0.001 inches to about 0.002 inches, and compriseporous ePTFE, having a porosity within the range of from about 10microns to about 100 microns.

The composite stack is heated to a temperature of from about 200.degree.F. to about 300.degree. F., for about 1 minute to about 5 minutes underpressure to provide a finished composite membrane assembly with anembedded frame 14 as illustrated schematically in FIG. 15. The finalcomposite membrane has a thickness within the range of from about 0.001inches to about 0.010 inches, and, preferably, is about 0.002 to about0.003 inches in thickness. However, the thicknesses and processparameters of the foregoing may be varied considerably, depending uponthe materials of the bonding layer 254 the first layer 250 and thesecond layer 252.

As illustrated in top plan view in FIG. 16, the resulting finishedcomposite membrane has a plurality of “unbonded” windows or areas 256suitable for cellular attachment and/or ingrowth. The attachment areas256 are bounded by the frame 14 struts, and the cross-hatch or otherwall pattern formed by the bonding layer 254. Preferably, a regularwindow 256 pattern is produced in the bonding layer 254.

The foregoing procedure allows the bonding mesh to flow into the firstand second membranes 250 and 252 and gives the composite membrane 15greater strength (both tensile and tear strength) than the componentswithout the bonding mesh. The composite allows uniform bonding whilemaintaining porosity of the membrane 15, to facilitate tissueattachment. By flowing the thermoplastic bonding layer into the pores ofthe outer mesh layers 250 and 252, the composite flexibility ispreserved and the overall composite layer thickness can be minimized.

Referring back to FIGS. 1 and 2, the occlusion device 10 may be furtherprovided with a bulking element or stabilizer 194. The stabilizer 194may be spaced apart along an axis from the occluding member 11. In theillustrated embodiment, a distal end 190 and a proximal end 192 areidentified for reference. The designation proximal or distal is notintended to indicate any particular anatomical orientation or deploymentorientation within the deployment catheter. As shown in FIGS. 1 and 2,the stabilizer 194 is spaced distally apart from the occluding member11.

For use in the LAA, the occluding member 11 has an expanded diameterwithin the range of from about 1 cm to about 5 cm, and, in oneembodiment, about 3 cm. The axial length of the occluding member 11 inan expanded, unstressed orientation from the distal end 192 to the hub16 is on the order of about 1 cm. The overall length of the occlusiondevice 10 from the distal end 192 to the proximal end 190 is within therange of from about 1.5 cm to about 4 cm and, in one embodiment, about2.5 cm. The axial length of the stabilizer 194 between distal hub 191and proximal hub 16 is within the range of from about 0.5 cm to about 2cm, and, in one embodiment, about 1 cm. The expanded diameter of thestabilizer 194 is within the range of from about 0.5 cm to about 2.5 cm,and, in one embodiment, about 1.4 cm. The outside diameter of the distalhub 191 and proximal hub 16 is about 2.5 mm.

Preferably, the occlusion device 10 is provided with one or moreretention structures for retaining the device in the left atrialappendage or other body cavity or lumen. In the illustrated embodiment,a plurality of barbs or other anchors 195 are provided, for engagingadjacent tissue to retain the occlusion device 10 in its implantedposition and to limit relative movement between the tissue and theocclusion device. The illustrated anchors are provided on one or more ofthe spokes 17, or other portion of frame 14. Preferably, every spoke,every second spoke or every third spoke are provided with one or two ormore anchors each.

The illustrated anchor is in the form of a barb, with one on each spokefor extending into tissue at or near the opening of the LAA. Dependingupon the embodiment, two or three barbs may alternatively be desired oneach spoke. In the single barb embodiment of FIG. 7, each barb isinclined in a proximal direction. This is to inhibit proximal migrationof the implant out of the left atrial appendage. In this context, distalrefers to the direction into the left atrial appendage, and proximalrefers to the direction from the left atrial appendage into the heart.

Alternatively, one or more barbs may face distally, to inhibit distalmigration of the occlusion device deeper into the LAA. Thus the implantmay be provided with at least one proximally facing barb and at leastone distally facing barb. For example, in an embodiment of the typeillustrated in FIG. 12, discussed below, a proximal plurality of barbsmay be inclined in a first direction, and a distal plurality of barbsmay be inclined in a second direction, to anchor the implant againstboth proximal and distal migration.

One or more anchors 195 may also be provided on the stabilizer 194, suchthat it assists not only in orienting the occlusion device 10 andresisting compression of the LAA, but also in retaining the occlusiondevice 10 within the LAA. Any of a wide variety of structures may beutilized for anchor 195, either on the occluding member 11 or thestabilizer 194 or both, such as hooks, barbs, pins, sutures, adhesives,ingrowth surfaces and others which will be apparent to those of skill inthe art in view of the disclosure herein.

In use, the occlusion device 10 is preferably positioned within atubular anatomical structure to be occluded such as the left atrialappendage. In a left atrial appendage application, the occluding member11 is positioned across or near the opening to the LAA and thestabilizer 194 is positioned within the LAA. The stabilizer 194 assistsin the proper location and orientation of the occluding member 11, aswell as resists compression of the LAA behind the occluding member 11.The present inventors have determined that following deployment of anoccluding member 11 without a stabilizer 194 or other bulking structureto resist compression of the LAA, normal operation of the heart maycause compression and resulting volume changes in the LAA, therebyforcing fluid past the occluding member 11 and inhibiting or preventinga complete seal. Provision of a stabilizer 194 dimensioned to preventthe collapse or pumping of the LAA thus minimizes leakage, and provisionof the barbs facilitates endothelialization or other cell growth acrossthe occluding member 11.

The stabilizer 194 is preferably movable between a reducedcross-sectional profile for transluminal advancement into the leftatrial appendage, and an enlarged cross-sectional orientation asillustrated to fill or to substantially fill a cross-section through theLAA. The stabilizing member may enlarge to a greater cross section thanthe (pre-stretched) anatomical cavity, to ensure a tight fit andminimize the likelihood of compression. One convenient constructionincludes a plurality of elements 196 which are radially outwardlyexpandable in response to axial compression of a distal hub 191 towardsa proximal hub 16. Elements 196 each comprise a distal segment 198 and aproximal segment 202 connected by a bend 200. The elements 196 may beprovided with a bias in the direction of the radially enlargedorientation as illustrated in FIG. 2, or may be radially expanded byapplying an expansion force such as an axially compressive force betweendistal hub 191 and proximal hub 16 or a radial expansion force such asmight be applied by an inflatable balloon. Elements 196 may convenientlybe formed by laser cutting the same tube stock as utilized to constructthe distal hub 191, proximal hub 16 and frame 14, as will be apparent tothose of skill in the art in view of the disclosure herein.Alternatively, the various components of the occlusion device 10 may beseparately fabricated or fabricated in subassemblies and securedtogether during manufacturing.

As a post implantation step for any of the occlusion devices disclosedherein, a radiopaque dye or other visualizeable media may be introducedon one side or the other of the occlusion device, to permitvisualization of any escaped blood or other fluid past the occlusiondevice. For example, in the context of a left atrial appendageapplication, the occlusion device may be provided with a central lumenor other capillary tube or aperture which permits introduction of avisualizeable dye from the deployment catheter through the occlusiondevice and into the entrapped space on the distal side of the occlusiondevice. Alternatively, dye may be introduced into the entrapped spacedistal to the occlusion device such as by advancing a small gauge needlefrom the deployment catheter through the barrier 15 on the occlusiondevice, to introduce dye.

Modifications to the occlusion device 10 are illustrated in FIGS. 3-4.The occlusion device 10 comprises an occlusion member 11 and astabilizing member 194 as previously discussed. In the presentembodiment, however, each of the distal segments 198 inclines radiallyoutwardly in the proximal direction and terminates in a proximal end204. The proximal end 204 may be provided with an atraumaticconfiguration, for pressing against, but not penetrating, the wall ofthe left atrial appendage or other tubular body structure. Three or moredistal segments 198 are preferably provided, and generally anywherewithin the range of from about 6 to about 20 distal segments 198 may beused. In one embodiment, 9 distal segments 198 are provided. In thisembodiment, three of the distal segments 198 have an axial length ofabout 5 mm, and 6 of the distal segments 198 have an axial length ofabout 1 cm. Staggering the lengths of the distal segments 198 mayaxially elongate the zone in the left atrial appendage against which theproximal ends 204 provide anchoring support for the occlusion device.

The occlusion device 10 illustrated in FIGS. 3 and 4 is additionallyprovided with a hinge 206 to allow the longitudinal axis of theocclusion member 11 to be angularly oriented with respect to thelongitudinal axis of the stabilizing member 194. In the illustratedembodiment, the hinge 206 is a helical coil, although any of a varietyof hinge structures can be utilized. The illustrated embodiment may beconveniently formed by laser cutting a helical slot through a section ofthe tube from which the principal structural components of the occlusiondevice 10 are formed. At the distal end of the hinge 206, an annularband 208 connects the hinge 206 to a plurality of axially extendingstruts 210. In the illustrated embodiment, three axial struts 210 areprovided, spaced equilaterally around the circumference of the body.Axial struts 210 may be formed from a portion of the wall of theoriginal tube stock, which portion is left in its original axialorientation following formation of the distal segments 198 such as bylaser cutting from the tubular wall.

The occlusion member 11 is provided with a proximal zone 212 on each ofthe spokes 17. Proximal zone 212 has an enhanced degree of flexibility,to accommodate the fit between the occlusion member 11 and the wall ofthe left atrial appendage. Proximal section 212 may be formed byreducing the cross sectional area of each of the spokes 17, which may beprovided with a wave pattern as illustrated.

Each of the spokes 17 terminates in a proximal point 214. Proximal point214 may be contained within layers of the barrier 15, or may extendthrough or beyond the barrier 15 such as to engage adjacent tissue andassist in retaining the occlusion device 10 at the deployment site.

Referring to FIGS. 5 and 6, a further variation on the occlusion device10 illustrated in FIGS. 1 and 2 is provided. The occlusion device 10 isprovided with a proximal face 216 on the occlusion member 11, instead ofthe open and proximally concave face on the embodiment of FIGS. 1 and 2.The proximal face 216 is formed by providing a proximal spoke 218 whichconnects at an apex 220 to some or all of the distal spokes 17. Theproximal spoke 218, and corresponding apex 220 and distal spoke 17 maybe an integral structure, such as a single ribbon or wire, or elementcut from a tube stock as has been discussed.

Proximal spokes 218 are each attached to a hub 222 at the proximal end192 of the occlusion device 10. The barrier 15 may surround either theproximal face or the distal face or both on the occlusion member 11. Ingeneral, provision of a proximal spoke 218 connected by an apex 220 to adistal spoke 17 provides a greater radial force than a distal spoke 17alone, which will provide an increased resistance to compression if theocclusion member 11 is positioned with the LAA.

Referring to FIGS. 7-12, alternate structures of the occlusion device inaccordance with the present invention are illustrated. In general, theocclusion device 10 comprises an occluding member but does not include adistinct stabilizing member as has been illustrated in connection withprevious embodiments. Any of the embodiments previously disclosed hereinmay also be constructed using the occluding member only, and omittingthe stabilizing member as will be apparent to those of skill in the artin view of the disclosure herein.

The occluding device 10 comprises a proximal end 192, a distal end 190,and a longitudinal axis extending therebetween. A plurality of supports228 extend between a proximal hub 222 and a distal hub 191. At least twoor three supports 228 are provided, and preferably at least about ten.In one embodiment, sixteen supports 228 are provided. However, theprecise number of supports 228 can be modified, depending upon thedesired physical properties of the occlusion device 10 as will beapparent to those of skill in the art in view of the disclosure herein,without departing from the present invention.

Each support 228 comprises a proximal spoke portion 218, a distal spokeportion 17, and an apex 220 as has been discussed. Each of the proximalspoke portion 218, distal spoke portion 17 and apex 220 may be a regionon an integral support 228, such as a continuous rib or frame memberwhich extends in a generally curved configuration as illustrated with aconcavity facing towards the longitudinal axis of the occlusion device10. Thus, no distinct point or hinge at apex 220 is necessarilyprovided.

At least some of the supports 228, and, preferably, each support 228, isprovided with one or two or more barbs 195. In the illustratedconfiguration, the occlusion device 10 is in its enlarged orientation,such as for occluding a left atrial appendage or other body cavity orlumen. In this orientation, each of the barbs 195 projects generallyradially outwardly from the longitudinal axis, and is inclined in theproximal direction. One or more barbs may also be inclined distally, asis discussed elsewhere herein. In an embodiment where the barbs 195 andcorresponding support 228 are cut from a single ribbon, sheet or tubestock, the barb 195 will incline radially outwardly at approximately atangent to the curve formed by the support 228.

The occlusion device 10 constructed from the frame illustrated in FIG. 7may be constructed in any of a variety of ways, as will become apparentto those of skill in the art in view of the disclosure herein. In onemethod, the occlusion device 10 is constructed by laser cutting a pieceof tube stock to provide a plurality of axially extending slotsin-between adjacent supports 228. Similarly, each barb 195 can be lasercut from the corresponding support 228 or space in-between adjacentsupports 228. The generally axially extending slots which separateadjacent supports 228 end a sufficient distance from each of theproximal end 192 and distal end 190 to leave a proximal hub 222 and adistal hub 191 to which each of the supports 228 will attach. In thismanner, an integral cage structure may be formed. Alternatively, each ofthe components of the cage structure may be separately formed andattached together such as through soldering, brazing, heat bonding,adhesives, and other fastening techniques which are known in the art. Afurther method of manufacturing the occlusion device 10 is to laser cuta slot pattern on a flat sheet of appropriate material, such as aflexible metal or polymer, as has been discussed in connection withprevious embodiments. The flat sheet may thereafter be rolled about anaxis and opposing edges bonded together to form a tubular structure.

The apex portion 220 which carries the barb 195 may be advanced from alow profile orientation in which each of the supports 228 extendgenerally parallel to the longitudinal axis, to an implanted orientationas illustrated, in which the apex 220 and the barb 195 are positionedradially outwardly from the longitudinal axis. The support 228 may bebiased towards the enlarged orientation, or may be advanced to theenlarged orientation under positive force following positioning withinthe tubular anatomical structure, in any of a variety of manners.

For an example of enlarging under positive force, referring to FIG. 8,an inflatable balloon 230 is positioned within the occlusion device 10.Inflatable balloon 230 is connected by way of a removable coupling 232to an inflation catheter 234. Inflation catheter 234 is provided with aninflation lumen for providing communication between an inflation mediasource 236 outside of the patient and the balloon 230. Followingpositioning within the target body lumen, the balloon 230 is inflated,thereby engaging barbs 195 with the surrounding tissue. The inflationcatheter 234 is thereafter removed, by decoupling the removable coupling232, and the inflation catheter 234 is thereafter removed. The balloon230 may be either left in place within the occlusion device 10, ordeflated and removed by the inflation catheter 234.

In an alternate embodiment, the supports 228 are radially enlarged suchas through the use of a deployment catheter 238. See FIG. 9. Deploymentcatheter 238 comprises a lumen for movably receiving a deploymentelement such as a flexible line 240. Deployment line 240 extends in aloop 244 formed by an aperture or slip knot 242. As will be apparentfrom FIG. 9, proximal retraction on the deployment line 240 whileresisting proximal movement of proximal hub 222 such as by using thedistal end of the catheter 238 will cause the distal hub 191 to be drawntowards the proximal hub 222, thereby radially enlarging thecross-sectional area of the occlusion device 10. Depending upon thematerial utilized for the occlusion device 10, the supports 228 willretain the radially enlarged orientation by elastic deformation, or maybe retained in the enlarged orientation such as by securing the slipknot 242 immovably to the deployment line 240 at the fully radiallyenlarged orientation. This may be accomplished in any of a variety ofways, using additional knots, clips, adhesives, or other techniquesknown in the art.

A variety of alternative structures may be utilized, to open or enlargethe occlusion device 10 under positive force. For example, referring toFIG. 9, a pull wire 240 may be removably attached to the distal hub 191or other distal point of attachment on the occlusion device 10. Proximalretraction of the pull wire 240 while resisting proximal motion of theproximal hub 222 such as by using the distal end of the catheter 238will cause enlargement of the occlusion device 10 as has been discussed.The pull wire 240 may then be locked with respect to the proximal hub222 and severed or otherwise detached to enable removal of thedeployment catheter 238 and retraction of the pull wire 240. Locking ofthe pull wire with respect to the proximal hub 222 may be accomplishedin any of a variety of ways, such as by using interference fit orfriction fit structures, adhesives, a knot or other technique dependingupon the desired catheter design.

Referring to FIGS. 10 and 11, the occlusion device 10 may be providedwith a barrier 15 such as a mesh or fabric as has been previouslydiscussed. Barrier 15 may be provided on only one hemisphere such asproximal face 216, or may be carried by the entire occlusion device 10from proximal end 192 to distal end 190. The barrier may be secured tothe radially inwardly facing surface of the supports 228, as illustratedin FIG. 11, or may be provided on the radially outwardly facing surfacesof supports 228, or both.

A further embodiment of the occlusion device 10 is illustrated in FIG.12, in which the apex 220 is elongated in an axial direction to provideadditional contact area between the occlusion device 10 and the wall ofthe tubular structure. In this embodiment, one or two or three or moreanchors 195 may be provided on each support 228, depending upon thedesired clinical performance. The occlusion device 10 illustrated inFIG. 12 may also be provided with any of a variety of other featuresdiscussed herein, such as a partial or complete barrier 15. In addition,the occlusion device 10 illustrated in FIG. 12 may be enlarged using anyof the techniques disclosed elsewhere herein.

Referring to FIG. 17, there is schematically illustrated a furtherembodiment of the present invention. An adjustable implant deploymentsystem 300 comprises generally a catheter 302 for placing a detachableimplant 304 within a body cavity or lumen, as has been discussed. Thecatheter 302 comprises an elongate flexible tubular body 306, extendingbetween a proximal end 308 and a distal end 310. The catheter is shownin highly schematic form, for the purpose of illustrating the functionalaspects thereof. In one embodiment, the catheter body will have asufficient length and diameter to permit percutaneous entry into thevascular system, and transluminal advancement through the vascularsystem to the desired deployment site. For example, in an embodimentintended for access at the femoral vein and deployment within the leftatrial appendage, the catheter 302 will have a length within the rangeof from about 50 cm to about 150 cm, and a diameter of generally no morethan about 15 French. Those skilled in the art recognize that theimplant deployment system 300 can be configured and sized for variousmethods of deploying implant 304, as described below. The catheter 302can be sized and configured so that an implant 304 can be deliveredusing, for example, conventional transthoracic surgical, minimallyinvasive, or port access approaches. The deployment system 300 can beused to deploy the implant 304 using methods shown in FIGS. 40-42 anddescribed below. Further dimensions and physical characteristics ofcatheters for navigation to particular sites within the body are wellunderstood in the art.

The tubular body 306 is further provided with a handle 309 generally onthe proximal end 308 of the catheter 302. The handle 309 permitsmanipulation of the various aspects of the implant deployment system300, as will be discussed below. Handle 309 may be manufactured in anyof a variety of ways, typically by injection molding or otherwiseforming a handpiece for single-hand operation, using materials andconstruction techniques well known in the medical device arts.

The implant 304 may be in the form of any of those described previouslyherein, as modified below. In general, the implant is movable from areduced crossing profile to an enlarged crossing profile, such that itmay be positioned within a body structure and advanced from its reducedto its enlarged crossing profile to obstruct blood flow or perform otherfunctions while anchored therein. The implant 304 may be biased in thedirection of the enlarged crossing profile, may be neutrally biased ormay be biased in the direction of the reduced crossing profile. Anymodifications to the device and deployment system to accommodate thesevarious aspects of the implant 304 may be readily accomplished by thoseof skill in the art in view of the disclosure herein.

In the illustrated embodiment, the distal end 314 of the implant 304 isprovided with an implant plug 316. Implant plug 316 provides a stoppingsurface 317 for contacting an axially movable core 312. The core 312extends axially throughout the length of the catheter body 302, and isattached at its proximal end to a core control 332 on the handle 309.

The core 312 may comprise any of a variety of structures which hassufficient lateral flexibility to permit navigation of the vascularsystem, and sufficient axial column strength to enable reduction of theimplant 304 to its reduced crossing profile. Any of a variety ofstructures such as hypotube, solid core wire, “bottomed out” coil springstructures, or combinations thereof may be used, depending upon thedesired performance of the finished device. In one embodiment, the core312 comprises stainless steel tubing.

The distal end of core 312 is positioned within a recess or lumen 322defined by a proximally extending guide tube 320. In the illustratedembodiment, the guide tube 320 is a section of tubing such as metalhypotube, which is attached at the distal end 314 of the implant andextends proximally within the implant 304. The guide tube 320 preferablyextends a sufficient distance in the proximal direction to inhibitbuckling or prolapse of the core 312 when distal pressure is applied tothe core control 332 to reduce the profile of the implant 304. However,the guide tube 320 should not extend proximally a sufficient distance tointerfere with the opening of the implant 304.

As will be appreciated by reference to FIG. 17, the guide tube 320 mayoperate as a limit on distal axial advancement of the proximal end 324of implant 304. Thus, the guide tube 320 preferably does not extendsufficiently far proximally from the distal end 314 to interfere withoptimal opening of the implant 304. The specific dimensions aretherefore relative, and will be optimized to suit a particular intendedapplication. In one embodiment, the implant 304 has an implanted outsidediameter within the range of from about 5 mm to about 45 mm, and anaxial implanted length within the range of from about 5 mm to about 45mm. The guide tube 320 has an overall length of about 3 mm to about 35mm, and an outside diameter of about 0.095 inches.

An alternate guide tube 320 is schematically illustrated in FIG. 18. Inthis configuration, the guide tube 320 comprises a plurality of tubularsegments 321 spaced apart by an intervening space 323. This allowsincreased flexibility of the guide tube 320, which may be desirableduring the implantation step, while retaining the ability of the guidetube 320 to maintain linearity of the core 312 while under axialpressure. Although three segments 321 are illustrated in FIG. 18, asmany as 10 or 20 or more segments 321 may be desirable depending uponthe desired flexibility of the resulting implant.

Each adjacent pair of segments 321 may be joined by a hinge element 325which permits lateral flexibility. In the illustrated embodiment, thehinge element 325 comprises an axially extending strip or spine, whichprovides column strength along a first side of the guide tube 320. Theguide tube 320 may therefore be curved by compressing or extending asecond side of the guide tube 320 which is generally offset from thespine 325 by about 180.degree. A limit on the amount of curvature may beset by adjusting the axial length of the space 323 between adjacentsegments 321. In an embodiment having axial spines 325, each axial spine325 may be rotationally offset from the next adjacent axial spine 325 toenable flexibility of the overall guide tube 320 throughout a360.degree. angular range of motion.

Alternatively, the flexible hinge point between each adjacent segment321 may be provided by cutting a spiral groove or plurality of parallelgrooves in a tubular element in between what will then become eachadjacent pair of segments 321. In this manner, each tubular element 321will be separated by an integral spring like structure, which can permitflexibility. As a further alternative, the entire length of the guidetube 320 may comprise a spring. Each of the forgoing embodiments may bereadily constructed by laser cutting or other cutting from a piece oftube stock, to produce a one piece guide tube 320. Alternatively, theguide tube 320 may be assembled from separate components and fabricatedtogether using any of a variety of bonding techniques which areappropriate for the construction material selected for the tube 320.

Various distal end 314 constructions may be utilized, as will beapparent to those of skill in the art in view of the disclosure herein.In the illustrated embodiment, the distal implant plug 316 extendswithin the implant 304 and is attached to the distal end of the guidetube 320. The implant plug 316 may be secured to the guide tube 320 andimplant 304 in any of a variety of ways, depending upon the variousconstruction materials. For example, any of a variety of metal bondingtechniques such as a welding, brazing, interference fit such as threadedfit or snap fit, may be utilized. Alternatively, any of a variety ofbonding techniques for dissimilar materials may be utilized, such asadhesives, and various molding techniques. In one construction, theimplant plug 316 comprises a molded polyethylene cap, and is held inplace utilizing a distal cross pin 318 which extends through the implant304, the guide tube 320 and the implant plug 316 to provide a secure fitagainst axial displacement.

The proximal end 324 of the implant 304 is provided with a releasablelock 326 for attachment to a release element such as pull wire 328. Pullwire 328 extends proximally throughout the length of the tubular body306 to a proximal pull wire control 330 on the handle 309.

As used herein, the term pull wire is intended to include any of a widevariety of structures which are capable of transmitting axial tension orcompression such as a pushing or pulling force with or without rotationfrom the proximal end 308 to the distal end 310 of the catheter 302.Thus, monofilament or multifilament metal or polymeric rods or wires,woven or braided structures may be utilized. Alternatively, tubularelements such as a concentric tube positioned within the outer tubularbody 306 may also be used as will be apparent to those of skill in theart.

In the illustrated embodiment, the pull wire 328 is releasably connectedto the proximal end 324 of the implant 304. This permits proximaladvancement of the proximal end of the implant 304, which cooperateswith a distal retention force provided by the core 312 against thedistal end of the implant to axially elongate the implant 304 therebyreducing it from its implanted configuration to its reduced profile forimplantation. The proximal end of the pull wire 328 may be connected toany of a variety of pull wire controls 330, including rotational knobs,levers and slider switches, depending upon the design preference.

The proximal end 324 of the implant 304 is thus preferably provided witha releasable lock 326 for attachment of the pull wire 328 to thedeployment catheter. In the illustrated embodiment, the releasable lockis formed by advancing the pull wire distally around a cross pin 329,and providing an eye or loop which extends around the core 312. As longas the core 312 is in position within the implant 304, proximalretraction of the pull wire 328 will advance the proximal end 324 of theimplant 304 in a proximal direction. See FIG. 17A. However, followingdeployment, proximal retraction of the core 312 such as by manipulationof the core control 332 will pull the distal end of the core 312 throughthe loop on the distal end of the pull wire 328. The pull wire 328 maythen be freely proximally removed from the implant 304, thereby enablingdetachment of the implant 304 from the deployment system 300 within atreatment site. See FIG. 17B.

The implant deployment system 300 thus permits the implant 304 to bemaintained in a low crossing profile configuration, to enabletransluminal navigation to a deployment site. Following positioning ator about the desired deployment site, proximal retraction of the core312, or distal movement of full wire 528, enables the implant 304 toradially enlarge under its own bias to fit the surrounding tissuestructure. Alternatively, the implant can be enlarged under positiveforce, such as by inflation of a balloon or by a mechanical mechanism asis discussed elsewhere herein. Once the clinician is satisfied with theposition of the implant 304, such as by injection of dye andvisualization using conventional techniques, the core 312 is proximallyretracted thereby releasing the lock 326 and enabling detachment of theimplant 304 from the deployment system 300.

If, however, visualization reveals that the implant 304 is not at thelocation desired by the clinician, proximal retraction of the pull wire328 with respect to the core 312 will radially reduce the diameter ofthe implant 304, thereby enabling repositioning of the implant 304 atthe desired site. Thus, the present invention permits the implant 304 tobe enlarged or reduced by the clinician to permit repositioning and/orremoval of the implant 304 as may be desired.

In an alternate construction, the implant may be radially enlarged orreduced by rotating a torque element extending throughout the deploymentcatheter. Referring to FIG. 19, the elongate flexible tubular body 306of the deployment catheter 302 includes a rotatable torque rod 340extending axially therethrough. The proximal end of the torque rod 340may be connected at a proximal manifold to a manual rotation device suchas a hand crank, thumb wheel, rotatable knob or the like. Alternatively,the torque rod 340 may be connected to a power driven source ofrotational energy such as a motor drive or air turbine.

The distal end of the torque rod 340 is integral with or is connected toa rotatable core 342 which extends axially through the implant 304. Adistal end 344 of the rotatable core 342 is positioned within a cavity322 as has been discussed.

The terms torque rod or torque element are intended to include any of awide variety of structures which are capable of transmitting arotational torque throughout the length of a catheter body. For example,solid core elements such as stainless steel, nitinol or other nickeltitanium alloys, or polymeric materials may be utilized. In anembodiment intended for implantation over a guidewire, the torque rod340 is preferably provided with an axially extending central guidewirelumen. This may be accomplished by constructing the torque rod 340 froma section of hypodermic needle tubing, having an inside diameter of fromabout 0.001 inches to about 0.005 inches or more greater than theoutside diameter of the intended guidewire. Tubular torque rods 340 mayalso be fabricated or constructed utilizing any of a wide variety ofpolymeric constructions which include woven or braided reinforcinglayers in the wall. Torque transmitting tubes and their methods ofconstruction are well understood in the intracranial access androtational atherectomy catheter arts, among others, and are notdescribed in greater detail herein. Use of a tubular torque rod 340 alsoprovides a convenient infusion lumen for injection of contrast mediawithin the implant 304, such as through a port 343.

The proximal end 324 of the implant 304 is provided with a threadedaperture 346 through which the core 342 is threadably engaged. As willbe appreciated by those of skill in the art in view of the disclosureherein, rotation of the threaded core 342 in a first direction relativeto the proximal end 324 of the implant 304 will cause the rotatable core342 to advance distally. This distal advancement will result in an axialelongation and radial reduction of the implantable device 304. Rotationof the rotatable core 342 in a reverse direction will cause a proximalretraction of the rotatable core 342, thus enabling a radial enlargementand axial shortening of the implantable device 304.

The deployment catheter 302 is further provided with an antirotationlock 348 between a distal end 350 of the tubular body 306 and theproximal end 324 of the implant 304. In general, the rotational lock 348may be conveniently provided by cooperation between a first surface 352on the distal end 350 of the deployment catheter 302, which engages asecond surface 354 on the proximal end 324 of the implantable device304, to rotationally link the deployment catheter 302 and theimplantable device 304. Any of a variety of complementary surfacestructures may be provided, such as an axial extension on one of thefirst and second surfaces for coupling with a corresponding recess onthe other of the first and second surfaces. Such extensions and recessesmay be positioned laterally offset from the axis of the catheter.Alternatively, they may be provided on the longitudinal axis with any ofa variety of axially releasable anti-rotational couplings having atleast one flat such as a hexagonal or other multifaceted cross sectionalconfiguration.

As schematically illustrated in FIGS. 19A and B, one or more projections356 on the first surface 352 may engage a corresponding recess 358 onthe second surface 354. Any of a variety of alternative complementarysurface structures may also be provided, as will be apparent to those ofskill in the art in view of the disclosure herein. For example,referring to FIG. 19A, the projection 356 is in the form of an axiallyextending pin for engaging a complimentary recess 358 on the proximalend 324 of the implant 304. FIG. 19B illustrates an axially extendingspline 356 for receipt within a complimentary axially extending recess358. The various pin, spline and other structures may be reversedbetween the distal end of tubular body 306 and the proximal end 324 ofthe implant 304 as will be apparent to those of skill in the art in viewof the disclosure herein.

Upon placement of the implantable device 304 at the desired implantationsite, the torque rod 340 is rotated in a direction that produces anaxial proximal retraction. This allows radial enlargement of theradially outwardly biased implantable device 304 at the implantationsite. Continued rotation of the torque rod 340 will cause the threadedcore 342 to exit proximally through the threaded aperture 346. At thatpoint, the deployment catheter 302 may be proximally retracted from thepatient, leaving the implanted device 304 in place.

By modification of the decoupling mechanism to allow the core 342 to bedecoupled from the torque rod 340, the rotatable core 342 may be leftwithin the implantable device 304, as may be desired depending upon theintended deployment mechanism. For example, the distal end of the core342 may be rotatably locked within the end cap 326, such as by includingcomplimentary radially outwardly or inwardly extending flanges andgrooves on the distal end of the core 342 and inside surface of thecavity 322. In this manner, proximal retraction of the core 342 byrotation thereof relative to the implantable device 304 will pull theend cap 326 in a proximal direction under positive force. This may bedesirable as a supplement to or instead of a radially enlarging biasbuilt into the implantable device 304.

In the embodiment illustrated in FIG. 19, or any other of the deploymentand/or removal catheters described herein, the distal end of the tubularbody 306 may be provided with a zone or point of enhanced lateralflexibility. This may be desirable in order allow the implant to seat inthe optimal orientation within the left atrial appendage, and not berestrained by a lack of flexibility in the tubular body 306. This may beaccomplished in any of a variety of ways, such as providing the distalmost one or two or three centimeters or more of the tubular body 306with a spring coil configuration. In this manner, the distal end of thetubular body 306 will be sufficiently flexible to allow the implant 304to properly seat within the LAA. This distal flex zone on the tubularbody 306 may be provided in any of a variety of ways, such as by cuttinga spiral slot in the distal end of the tubular body 306 using lasercutting or other cutting techniques. The components within the tubularbody 306 such as torque rod 340 may similarly be provided with a zone ofenhanced flexibility in the distal region of the tubular body 306.

The implantable device 304 may also be retrieved and removed from thebody in accordance with a further aspect of the present invention. Onemanner of retrieval and removal will be understood in connection withFIGS. 20 through 20C. Referring to FIG. 20, a previously implanteddevice 304 is illustrated as releasably coupled to the distal end of thetubular body 306, as has been previously discussed. Coupling may beaccomplished by aligning the tubular body 306 with the proximal end 324of the deployed implant 304, under fluoroscopic visualization, anddistally advancing a rotatable core 342 through the threaded aperture346. Threadable engagement between the rotatable core 342 and aperture346 may thereafter be achieved, and distal advancement of core 342 willaxially elongate and radially reduce the implant 304.

The tubular body 306 is axially movably positioned within an outertubular delivery or retrieval catheter 360. Catheter 360 extends from aproximal end (not illustrated) to a distal end 362. The distal end 362is preferably provided with a flared opening, such as by constructing aplurality of petals 364 for facilitating proximal retraction of theimplant 304 as will become apparent. Petals 364 may be constructed in avariety of ways, such as by providing axially extending slits in thedistal end 362 of the delivery catheter 360. In this manner, preferablyat least about three, and generally at least about four or five or sixpetals or more will be provided on the distal end 362 of the deliverycatheter 360. Petals 364 manufactured in this manner would reside in afirst plane, transverse to the longitudinal axis of the deliverycatheter 360, if each of such petals 364 were inclined at 90 degrees tothe longitudinal axis of the delivery catheter 360.

In one application of the invention, a second layer of petals 365 areprovided, which would lie in a second, adjacent plane if the petals 365were inclined at 90 degrees to the longitudinal axis of the deliverycatheter 360. Preferably, the second plane of petals 365 is rotationallyoffset from the first plane of petals 364, such that the second petals365 cover the spaces 367 formed between each adjacent pair of petals365. The use of two or more layers of staggered petals 364 and 365 hasbeen found to be useful in retrieving implants 304, particularly whenthe implant 304 carries a plurality of tissue anchors 195.

The petals 364 and 365 may be manufactured from any of a variety ofpolymer materials useful in constructing medical device components suchas the delivery catheter 360. This includes, for example, polyethylene,PET, PEEK, PEBAX, and others well known in the art. The second petals365 may be constructed in any of a variety of ways. In one convenientconstruction, a section of tubing which concentrically fits over thedelivery catheter 360 is provided with a plurality of axially extendingslots in the same manner as discussed above. The tubing with a slotteddistal end may be concentrically positioned on the catheter 360, androtated such that the space between adjacent petals 365 is offset fromthe space between adjacent petals 364. The hub of the petals 365 maythereafter be bonded to the catheter 360, such as by heat shrinking,adhesives, or other bonding techniques known in the art.

The removal sequence will be further understood by reference to FIGS.20a through 20c . Referring to FIG. 20a , the radially reduced implant304 is proximally retracted part way into the delivery catheter 360.This can be accomplished by proximally retracting the tubular body 306and/or distally advancing the catheter 360. As illustrated in FIG. 20b ,the tubular body 306 having the implant 304 attached thereto isproximally retracted a sufficient distance to position the tissueanchors 195 within the petals 364. The entire assembly of the tubularbody 306, within the delivery catheter 360 may then be proximallyretracted within the transseptal sheath 366 (e.g., delivery sheath) orother tubular body as illustrated in FIG. 20c . The collapsed petals 364allow this to occur while preventing engagement of the tissue anchors195 with the distal end of the transseptal sheath 366 or body tissue.The entire assembly having the implantable device 304 contained thereinmay thereafter be proximally withdrawn from or repositioned within thepatient.

In FIGS. 21-21E there is provided another embodiment of an implant anddelivery system. Adjustable implant deployment system 300 comprisescatheter 302 and detachable implant 304 having a frame 506 and anchorsor barbs 195, as discussed in greater detail above with respect to FIG.17 and other figures. As illustrated in FIG. 21, the deployment system300 also includes a slider assembly 400. In the illustrated embodiment,slider assembly 400 includes a guide tube 320 extending proximally fromthe distal end or distal hub 314 of the implant, and a slider nut 402slidably received in a channel 430 of the guide tube 320. Slider nut 402preferably includes a flange 404 operable to travel within alongitudinal slot 410 that extends at least partially along the lengthof guide tube 320. The flange 404 of the slider nut 402 has a proximalsurface 406 and a distal surface 408. Slot 410 has a proximal surface412, and in one embodiment, extends through the distal end of the guidetube 320. Slot 410 may have a generally rectangular shape.

In the embodiment shown in FIG. 21, proximal movement of the flange 404within the slot 410, as well as proximal movement of the slider nut 402within the guide tube 320, is limited by interference between theproximal surfaces 406, 412, of flange 404 and guide tube 320,respectively, as slider nut 402 is moved in the proximal direction. Asshown in FIGS. 21A, 21C and 21D, distal movement of the flange 404within the slot 410, as well as distal movement of the slider nut 402within the guide tube 320, is limited by interference between theaxially moveable core 312 and the cross pin 318, as described in greaterdetail with reference to FIG. 21A below. In addition, flange 404prevents slider nut 402 from rotating within guide tube 320 due to theinterference between flange 404 and the side walls of the slot 410.

In one embodiment, the slot 410 of the guide tube 320 is laser-cut, andhas a length in the range between about 3 mm and 35 mm, and a width inthe range between about 0.5 mm and 2 mm. In one embodiment, the lengthof the guide tube 320 slot 410 is in the range between about 0.4 in andabout 0.826 in. In one embodiment, the width of the guide tube 320 slot410 is in the range between about 0.02 in and about 0.04 in. In oneembodiment, the slider nut 402 is a keyed polymer extrusion, and issized so that it fits and slides at least partially within the guidetube 320. Such material is advantageous in that it provides a reducedfriction interface between the slider nut 402 and the guide tube 320. Inother embodiments, the slider nut 402 is made from plastic, metal, orceramic. In another embodiment, the slider nut 402 is made from PEBAX,polyethylene, polyurethane, nickel titanium, or stainless steel. Flange404 may be integrally formed with the slider nut 402, or may be attachedto it. In one embodiment, flange 404 is made from plastic, and is sizedso that it fits and slides within the slot 410 of the guide tube 320.The exact length of the flange 404 is selected based upon the dimensionsof the slot 410, and will vary based upon the clinical parameters of theparticular treatment.

Several views of one embodiment of the adjustable implant deploymentsystem 300 of FIG. 21 are shown in FIGS. 21A-21E. FIG. 21A illustratesthe distal end 344 of an axially moveable core 312 similar to thatdescribed above, releasably coupled to a slider assembly 400. Sliderassembly 400 includes guide tube 320 and slider nut 402, as describedabove. Slider nut 402 includes a flange 404 as described above and amating surface 420 for receiving the distal end 344 of axially moveablecore 312. In one embodiment, mating surface 420 of nut 402 is aninternally threaded surface. Mating surface 420 of nut 402 engagesmating surface 422 of axially moveable core 312 to provide axialcoupling between the movement of the axially moveable core 312 and theslider nut 402. In the illustrated embodiment, mating surface 422 ofaxially moveable core 312 is an externally threaded surface on a distalsection of the axially moveable core which terminates proximal to thevery distal tip of the axially moveable core 312.

In one embodiment, the axially moveable core 312 includes a proximalshaft 576, a flexible core section 564, and a distal shaft 578 asdescribed in greater detail below with reference to FIG. 37. The distalshaft 578 includes a mating surface 584 (as shown on FIG. 37), whichcorresponds to the mating surface 422 of the axially moveable core 312as shown on FIG. 21A. The mating surface 422 of axially moveable core312 preferably is a threaded surface to facilitate releasable attachmentto the mating surface 420 of the slider nut 402. In one embodiment, themating surface 422 provides self-tapping functionality to the axiallymoveable core 312. The mating surface 422 of the axially moveable core312 includes threads, and is self-tapping as it is inserted into theslider nut 402 of the slider assembly 400. In one embodiment, the slidernut 402 contains a central lumen extending axially therethrough. In oneembodiment, the mating surface 420 of the slider nut 402 does notcontain threads, but is tapped (e.g., mating threads are created), asthe axially moveable core 312 is inserted into, and rotated with respectto the slider nut 402.

In one embodiment, the axially moveable core 312 preferably is attachedto the slider nut 402 by rotating the axially moveable core 312 suchthat the threads of the mating surface 422 of axially moveable core 312engage threads of the mating surface 420 of nut 402. Similarly, in oneembodiment, axially moveable core 312 is detached or decoupled from theslider nut 402 of the slider assembly 400 by rotating the axiallymoveable core 312 in the opposite direction. In one embodiment, as theaxially moveable core 312 is rotated in the detachment direction, thethreads of the mating surface 422 of axially moveable core 312 disengagethe threads of the mating surface 420 of nut 402, thereby releasing theaxially moveable core 312 from the slider nut 402, slider assembly 400,and implant 304. Additional description of the axially moveable core 312and contemplated alternative embodiments are provided below, includingthe illustration and discussion related to FIG. 37.

In the embodiment of FIGS. 21-21E, there is illustrated the axiallymoveable core 312 releasably coupled to the slider nut 402 of the sliderassembly 400 of an implant 304. In the illustrated embodiment, themating surface 422 of axially moveable core 312 is coupled with themating surface 420 of nut 402 such that the distal end surface 429 ofthe axially moveable core 312 and a marker 431 reside distal the slidernut 402 of the slider assembly 400. In one embodiment, the axiallymoveable core 312 is coupled to the slider nut 402 such that the marker431 resides approximately 1 to 3 mm distal the distal surface 418 ofslider nut 402. In other embodiments, the axially moveable core 312 iscoupled to the slider nut 402 of the slider assembly 400 such that thedistal surface 429 of the axially moveable core 312 and/or the marker431 reside within slider nut 402. Examples of such embodiments areprovided in greater detail below with reference to FIGS. 22A, 23, and26.

In one embodiment, axially moveable core 312 also includes a lumen 426.The lumen 426 preferably allows visualization dye to flow through thelumen 426 of the axially moveable core 312, through the lumen 428 of theimplant plug 316, and into the left atrial appendage. Such usage ofvisualization dye is useful for clinical diagnosis and testing of theposition of the implant 304 within the left atrial appendage or otherbody opening, as described in greater detail below.

The marker 431 as shown in FIGS. 21A, 21C and 21D advantageously assistsin locating the position of the distal end 344 of the axially moveablecore 312. In one embodiment, marker 431 comprises a radiopaque bandpress fit onto the distal end 344 of the axially moveable core 312.Marker 431 preferably is made from a material readily identified afterinsertion into a patient's body by using visualization techniques thatare well known to those of skill in the art. In one embodiment, themarker 431 is made from gold, or tungsten, or any such suitablematerial, as is well known to those of skill in the art. In anotherembodiment, marker 431 is welded, soldered, or glued onto the distal end344 of the axially moveable core 312. In one embodiment, marker 431 isan annular band and surrounds the circumference of the axially moveablecore 312. In other embodiments, the marker 431 does surround thecircumference of the axially moveable core 312. In other embodiments,marker 431 includes evenly or unevenly spaced marker segments. In oneembodiment, the use of marker segments is useful to discern the radialorientation of the implant 304 within the body.

In the embodiment of FIG. 21A, with axially moveable core 312threadingly engaged with slider nut 402, as axially moveable core 312 ismoved distally, distal surface 429 of axially moveable core 312 pressesagainst cross pin 318 to place or maintain implant 304 in a reduceddiameter configuration (such as in combination with pulling proximallyon pull wire 328, as discussed above). As tension on pull wire 328 isreduced, implant 304 assumes its expanded diameter configuration bybending under its own bias. Alternatively, in another embodiment,axially moveable core 312 is moved proximally, thereby relievingpressure on cross pin 318, and allowing implant 304 to assume itsexpanded diameter configuration. Expansion and reduction of implant 304diameter is described in greater detail above with reference to FIG. 17,and further below.

Once implant 304 of FIG. 21A assumes the expanded configuration, theaxially moveable core 312 and the slider nut 402 may be moved proximallyuntil the proximal surface 406 of flange 404 interferes with theproximal surface 412 of slot 410, without substantially affecting theshape or position of the implant 304. Similarly, once the implant 304assumes the expanded configuration, the axially moveable core 312 andslider nut 402 may be moved distally back until the distal surface 429of the axially moveable core 312 interferes with the cross pin 318, orimplant plug 316, without substantially affecting the shape or positionof the implant 304.

Such controllable axial decoupling between the movement of the axiallymoveable core 312 and the implant 304 is useful during delivery andexpansion of the implant 304. In addition, controllable axial decouplingis useful for testing the seal between the implant 304 and the leftatrial appendage once the implant 304 has been delivered, but beforereleasing the implant 304 from the catheter 302.

For example, it is clinically advantageous to provide axial decouplingbetween the axially moveable core 312 and the implant 304. Axialdecoupling assures that movement of the axially moveable core 312, aswell as other components of the adjustable implant deployment system 300that are coupled to the axially moveable core 312 (for example, but notlimited to the deployment handle 538 and the catheter 302, describedfurther below), do not substantially affect the shape or position of theimplant 304. Such axial decoupling prevents inadvertent movement of theaxially moveable core 312 or deployment handle 538 from affecting theshape or position of implant 304. For example, in one embodiment, if theuser inadvertently pulls or pushes the axially moveable core 312 or thedeployment handle, the position of the implant 304 within the leftatrial appendage preferably will not be substantially affected. Inaddition, axial decoupling also preferably prevents the motion of abeating heart from translating into movement of the axially moveablecore 312, the catheter 302, and the components coupled to the axiallymoveable core 312 and catheter 302, including the deployment handle. Bydecoupling the implant 304 from the axially moveable core 312 and othercomponents coupled to the axially moveable core 312, the risk ofaccidentally dislodging the implant 304 from the left atrial appendageduring testing is reduced.

There is illustrated in FIG. 22 another adjustable implant deploymentsystem 300 built in accordance with another embodiment of the presentinvention. The embodiment illustrated in FIG. 22 is similar to thatillustrated in FIG. 21. Adjustable implant deployment system 300comprises catheter 302 and detachable implant 304 as discussed ingreater detail above with respect to FIG. 17. The system 300 alsoincludes a slider assembly 400 having a guide tube 320 and slider nut402 slidably received therein. Slider nut 402 preferably includes aflange 404 operable to travel within the longitudinal slot 410 of theguide tube 320. The flange 404 of the slider nut 402 has a proximalsurface 406 and a distal surface 408. Slot 410 has a proximal surface412 and distal surface 414, and does not extend through the distal endof the guide tube 320. Slot 410 in one embodiment has a generallyrectangular shape.

The slider assembly 400 of FIG. 22 functions in a similar manner to thatillustrated and described with reference to FIGS. 21-21E. However, asshown in FIG. 22A, once the implant 304 assumes the expandedconfiguration, the axially moveable core 312 and slider nut 402 may bemoved distally until the distal surface 408 of flange 404 interfereswith the distal surface 414 of slot 410 and/or the distal surface ofslider nut 402 interferes with cross pin 318, without substantiallyaffecting the shape or position of the implant 304.

In one embodiment, the axially moveable core 312 of FIG. 22A is similarto that of FIG. 21A, except for the location of mating surface 422. Inthe embodiment illustrated in FIG. 22A, the mating surface 422 ofaxially moveable core 312 extends to the distal surface 429 of axiallymoveable core 312. In such configuration, the mating surface 422 ofaxially moveable core 312 preferably is contained within the slider nut402 of the slider assembly 400, as illustrated in FIG. 22A. The marker431 (not shown in FIG. 22A) of the axially moveable core 312 preferablyis attached to the axially moveable core 312 such that it does notinterfere with the coupling of the mating surface 420 of nut 402 andmating surface 422 of axially moveable core 312. For example, in oneembodiment, marker 431 is pressed, welded, soldered, glued or platedonto the lumen 426 of the axially moveable core 312, the distal surface429 of axially moveable core 312, or circumferentially around orpartially circumferentially around the axially moveable core 312 suchthat interference between mating surfaces 420, 422 does not occur. Inaddition, in the embodiment of FIG. 22A, the distal end 344 of axiallymoveable core 312 preferably is positioned within the slider nut 402 ofthe slider assembly 400, and does not extend past the distal surface 418of slider nut 402.

In the embodiment illustrated in FIG. 22A, slider nut 402 includes alumen 424 extending distally of core 312 that allows visualization dyeto flow from the lumen 426 of axially moveable core 312 through to thelumen 428 of the implant plug 316 and into the left atrial appendage.Such usage of visualization dye is described in greater detail below.

An illustration of an alternative implementation of a slider assembly isprovided in FIG. 23. FIG. 23 illustrates the distal end 344 of axiallymoveable core 312 coupled to a slider assembly 400 similar to thatdescribed above. In FIG. 23, slider assembly 400 includes a guide tube320 and a slider nut 402. Guide tube 320 includes a channel 430 in whichslider nut 402 travels as axially moveable core 312 is moved proximallyor distally. Proximal movement of the slider nut 402 is limited byinterference between proximal surface 416 of slider nut 402 and proximalridge 432 of guide tube 320. Distal movement of the slider nut 402 islimited by interference between distal surface 418 of slider nut 402 andthe distal ridge 434 of guide tube 320. Alternatively, distal movementof the slider nut 402 can be limited by interference between the distalsurface 418 of slider nut 402 and the cross pin 318, or the implant plug316, as shown in greater detail with reference to FIG. 22.

To prevent rotation of slider nut 402 within the guide tube 320, thecross-sectional shape of the channel 430 and slider nut 402 may have anon-circular shape. Examples of non-circular cross-sectional shapes ofslider nut 402 are illustrated with reference to FIG. 24 and FIG. 25.FIG. 24 illustrates one implementation in which the slider nut 402 andchannel 430 have an elliptical cross-sectional shape. FIG. 25illustrates another implementation in which the slider nut 402 and thechannel 430 have a rounded-rectangular cross-sectional shape. It is wellunderstood by those skilled in the art that the slider nut 402 andchannel 430 may have any non-circular shape so as to prevent rotation ofslider nut 402 within the guide tube 320.

Another implementation of one embodiment of the present invention isprovided with reference to FIG. 26. FIG. 26 illustrates the distal end344 of axially moveable core 312 removably coupled to a slider assembly400. As shown in FIG. 26, proximal movement of slider nut 402 is limitedby interference between proximal surface 416 of slider nut 402 andproximal ridge 432 of guide tube 320. Distal movement of slider nut 402is limited by interference between distal surface 429 of axiallymoveable core 312 and cross pin 318. The distal end 344 of the axiallymoveable core 312 is shown having a first diameter 433, a seconddiameter 435, and a step 437 therebetween. In other embodiments, thedistal end 344 of the axially moveable core 312 does not include suchfirst diameter 433, second diameter 435, and step 437. In oneembodiment, the axially moveable core 312 is screwed into the slider nut402 of the slider assembly 400 until the proximal surface 416 of slidernut 402 interferes with the step 437 of the axially moveable core 312.In another embodiment, the axially moveable core 312 is advanceddistally into the slider nut 402 of the slider assembly 400 as far asthe mating surface 420 of nut 402 and mating surface 422 of axiallymoveable core 312 permit. Axial rotation of slider nut 402 with respectto the guide tube 320 may be limited by providing slider nut 402 with anon-circular cross-sectional shape, as described in greater detailabove. An example of slider nut 402 having a non-circularcross-sectional shape is illustrated in FIG. 27. FIG. 27 shows thesectional view along cut line 27-27 of FIG. 26.

In another embodiment described with reference to FIG. 26A, a sliderassembly 400 does not include a slider nut 402. Instead, the distal end600 of an axially moveable core 312 includes an externally threaded,enlarged diameter, distal portion 602, and the proximal end 604 of aguide tube 320 includes an internally threaded, reduced diameter,proximal portion 606. The axially moveable core 312 is coupled to theguide tube 320 of the implant 304 by screwing the externally threaded,enlarged diameter, distal portion 602 of the axially moveable core 312into the internally threaded, reduced diameter, proximal portion 606 ofthe guide tube 320. Once coupled, the implant 304 is delivered to thedesired deployment site within the patient as described in furtherdetail herein. The axially moveable core 312 is then further manipulated(e.g., rotated in a clockwise direction), until the externally threaded,enlarged diameter, distal portion 602 of the axially moveable core 312enters the guide tube 320 of the implant 304, and becomes decoupled fromthe internally threaded, reduced diameter, proximal portion 606 of theguide tube 320, as shown in FIG. 26A.

Thereafter, proximal movement of the axially moveable core 312 withrespect to the implant 304 is limited by interference between a proximalsurface 608 of the external threads of the enlarged diameter, distalportion 602 of the axially moveable core 312, and a distal surface 610of the internal threads of the reduced diameter, proximal portion 606 ofthe guide tube 320. Distal movement of the axially moveable core 312with respect to the implant 304 is limited by interference between adistal surface 612 of the external threads of the enlarged diameter,distal portion 602 of the axially moveable core 312, and a cross pin318, as described in greater detail herein. Alternatively, distalmovement of the axially moveable core 312 with respect to the implant304 can be limited by interference between the distal surface 429 ofaxially moveable core 312 and the cross pin 318, as described in greaterdetail herein.

To remove the axially moveable core 312, the axially moveable core 312is moved proximally with respect to the implant 304 and manipulated(e.g., rotated counter-clockwise), until the external threads of theenlarged diameter, distal portion 602 of the axially moveable core 312engage the internal threads of the reduced diameter, proximal portion606 of the guide tube 320. The axially moveable core 312 is then furthermanipulated (e.g., rotated counter-clockwise), until the externalthreads of the enlarged diameter, distal portion 602 of the axiallymoveable core 312 disengage the internal threads of the reduceddiameter, proximal portion 606 of the guide tube 320 such that theaxially moveable core 312 may thereafter be removed from the patientwhile leaving the implant 304 in place.

In the embodiment of FIG. 26A described above, transverse movement of atleast a portion of the axially moveable core 312 with respect to theguide tube 320 and the implant 304 is decoupled over a limited range. Asillustrated, transverse movement is permitted by the outside diameter ofthe axially moveable core 312 being substantially smaller than theinside diameter of the proximal portion of the guide tube 320. Thispermits the core 312 to move transversely within the space defined bythe proximal portion of the guide tube. In other embodiments, transversemovement is permitted by controlling the relative dimensions of theinside diameter of the guide tube 320, the inside diameter of theproximal portion of the guide tube 320, the outside diameter of theaxially moveable core 312, the outside diameter of the slider nut 402,or a combination of any of the above, to provide space betweencorresponding parts of the device. It will be appreciated by those ofskill in the art that transverse movement may be provided with any ofthe embodiments described herein, including those that incorporate aslider nut 402 as part of the slider assembly 400. In one embodiment, asat least a portion of the axially moveable core 312 is moved in adirection transverse to the guide tube 320, the axially moveable core312 can also be positioned at an angle with respect to the longitudinalaxis of the guide tube 320 and implant 304.

FIG. 28 illustrates another implementation of a slider assembly 400. Theslider assembly 400 provides quick-disconnect functionality, and theability to release the axially moveable core 312 from the guide tube 320without using rotational forces. Such configuration is advantageous inthat rotational forces applied to the axially moveable core 312 tounscrew it from the guide tube 320 can, in some clinical situations,cause the implant 304 to rotate within or dislodge from the left atrialappendage. By using quick-disconnect functionality, such as thatillustrated in the embodiment of FIG. 28, the operator may decouple theaxially moveable core 312 from the guide tube 320 of the slider assembly400 by applying axial force instead of rotational force. An axial forcemay be particularly advantageous because in certain embodiments, theanchors 195 of the implant may provide greater resistance to axialmovement than to rotational movement, and thus be better able towithstand axial decoupling of the axially moveable core 312 from theslider assembly 400 than rotation decoupling.

In the illustrated embodiment of FIG. 28, slider assembly 400 includes aguide tube 320, shown coupled to an axially moveable core 312. Guidetube 320 includes a slot 410, as described in greater detail above withreference to FIG. 21. Axially moveable core 312 is preferably hollow andincludes a bending plug 436 near its distal end, a port 440 provided inthe core 312 adjacent plug 436, with a retractable lock 438 extendingthrough the lumen of the core 312. After axially moveable core 312 isinserted into the guide tube 320, retractable lock 438 is advanceddistally relative to the core 312 until it is guided by bending plug 436through the port 440 of axially moveable core 312. When properlypositioned, a distal tip 442 of retractable lock 438 extends into theslot 410 of the guide tube 320. The distal tip 442 of retractable lock438 limits axial movement of the axially moveable core 312 relative tothe guide tube 320 by interference between the distal tip 442 ofretractable lock 438 and the proximal and distal surfaces 412, 414 ofslot 410. Retractable lock 438 is made from a material or materialsflexible enough to bend as provided by bending plug 436, yet stiffenough to limit the motion of the axially moveable core 312 byinterfering with proximal and distal surfaces 412, 414 of slot 410. Inone embodiment, retractable lock 438 includes a spiral cut, transverseslots, or changes in material or thickness to control flexibility. Inone embodiment, the distal tip 442 of retractable lock 438 comprises amaterial that is stiffer, or less flexible than the retractable lock438.

In one embodiment, the retractable lock 438 is made from a flexiblewire, such as a nickel titanium or stainless steel. Alternatively,retractable lock 438 is made from metal hypotube, plastic, or otherbiocompatible material. In one embodiment, bending plug 436 is made frommetal, such as nickel titanium or stainless steel. Alternatively,bending plug 436 is made from plastic, or other biocompatible material.

An alternative embodiment of a slider assembly 400 is shown in FIG. 29.The slider assembly 400 of FIG. 29 also provides quick-disconnectfunctionality for release of axially moveable core 312 from guide tube320 by using non-rotational forces. As illustrated, slider assembly 400includes a guide tube 320, which comprises at least one slot 410. Twoopposing slots 410 are shown in the embodiment of FIG. 29. Axiallymoveable core 312 is coupled to guide tube 320 by quick-disconnectfunctionality.

Axially moveable core 312 in this embodiment includes a retractable lock438 in the form of an elongate key 439 extending through the lumen ofthe core 312, and two opposing ports 440 in axially moveable core 312through which two tabs 444 extend. The distal tip 442 of the key 439includes a contact surface 446 operable to engage contact surfaces 448of the tabs 444. The key 439 is moveable relative to the axiallymoveable core 312, and can be moved distally such that contact surface446 engages contact surfaces 448 of tabs 444, translating into radialmovement of tabs 444. Radial movement of tabs 444 causes them to projectinto slots 410 of the guide tube 320 by bending radially outwardly, andextending in a substantially radial direction. In one embodiment, thekey 439 is secured in place relative to the axially moveable core 312,so that the tabs 444 remain projected into the slots 410 of the guidetube 320. With the tabs 444 secured in place, axial movement of axiallymoveable core 312 preferably is limited by interference between the tabs444 and the proximal and distal surfaces 412, 414 of guide tube 320.

In one embodiment, the key 439 is made from an elongate wire, rod, ortube flexible enough for delivery through the adjustable implantdeployment system 300 described above, and strong enough to apply enoughforce to tabs 444 to achieve the functionality described above. In oneembodiment, the key 439 is made from stainless steel. The key 439preferably is locked in place relative to the axially moveable core 312by using a control, such as a thumbswitch or other such device as iswell known to those of skill in the art. For example, in one embodiment,the axially moveable core 312 is secured to the proximal portion of adeployment handle (not shown) such that the position of the axiallymoveable core 312 is fixed with respect to the deployment handle. A key439 preferably is inserted inside of the axially moveable core 312 suchthat it may slide axially within the axially moveable core 312. Theproximal portion of the key 439 preferably is coupled to a control, suchas, for example, a thumbswitch. The thumbswitch preferably is providedsuch that it may slide axially with respect to the deployment handle(and therefore with respect to the axially moveable core 312) over apredetermined range. By coupling the thumbswitch to the proximal portionof the key 439, axial movement of the key 439 with respect to theaxially moveable core 312 is achieved over the predetermined range. Inaddition, by locking the thumbswitch in place (by using mechanisms wellknown to those of skill in the art, such as release buttons, tabs, ortheir equivalents), the key 439 may be locked in place with respect tothe axially moveable core 312. Alternatively, switches, levers, buttons,dials, and similar devices well known to those of skill in the art maybe used instead of a thumbswitch as the control for the retractable lock438.

To decouple axially moveable core 312 from the guide tube 320,retractable lock 438 is released by moving key 439 proximally relativeto axially moveable core 312, thereby removing radial forces fromcontact surfaces 448 of tabs 444. In one embodiment, tabs 444 are biasedto bend inward upon the removal of the radial forces from their contactsurfaces 448. For example, tabs 444 preferably are constructed from aspring material, or a shape memory metal, such as, for example, nickeltitanium. Alternatively, in another embodiment, key 439 is moveddistally to decouple axially moveable core 312 from the guide tube 320.For example, in one embodiment, key 439 includes a cutout, notch, orslot along at least a portion of its distal end. In one embodiment, asthe key 439 is moved distally, the cutout, notch, or slot is moved suchthat it engages the tabs 444, allowing them to flex inwardly preferablyunder their own bias. In another embodiment, tabs 444 are biased to bendoutward upon removal of a radial force from a contact surface 448, andbend inward upon application of a radial force to contact surface 448.In such embodiment, the key 439 preferably is advanced distally to applyforce on a contact surface 448 such that tabs 444 are directed inward.In one embodiment, the key 439 is advanced proximally to apply force ona contact surface 448 such that tabs 444 are directed inward.

Alternative mechanisms for coupling the axially moveable core 312 to theslider assembly 400 may be used in addition to or instead of thosedescribed above. In one embodiment, the mating surface 420 of nut 402and mating surface 422 of axially moveable core 312 may include at leastone slot and at least one pin, respectively, such that axially moveablecore 312 couples with the slider nut 402 by a bayonet mount. In one suchembodiment, axially moveable core 312 is proximally advanced until theat least one slot of its mating surface 422 receives the at least onepin of the mating surface 420 of the nut 402. Axially moveable core 312is subsequently rotated to lock the axially moveable core 312 withrespect to the slider nut 402. Axially moveable core 312 may bedecoupled from slider nut 402 by rotating it in the opposite direction.

Referring to FIGS. 29A-G, in one embodiment, the axially moveable core312 is coupled to the guide tube 320 of the slider assembly 400 with abayonet mount 450. In one embodiment, the bayonet mount 450 includes aguide tube 320, which includes an un-threaded channel 430, and amaze-type slot 452. In one embodiment, the maze-type slot 452 includesat least one entry portion 454 extending in an axial direction, and atleast one keyed portion 456 extending at least partially in a non-axialdirection. In one embodiment, the maze-type slot 452 extends from theproximal edge 458 of the guide tube 320 in the distal direction, thenextends in a direction substantially transverse the axis of the guidetube 320, and then extends axially, either in the proximal or distaldirection, or both, such as shown for example, in FIGS. 29E and 29F. Themating surface 422 of the axially moveable core 312 includes a flange460, pin, or equivalent structure, which engages the maze-type slot 452of the guide tube 320. An example of one such flange 460 is illustratedin FIG. 29B. By manipulating the flange 460 of the axially moveable core312 with respect to the maze-type slot 452 of the guide tube 320according to a predetermined sequence, the axially moveable core 312 maybe coupled to the detachable implant 304. In addition, the shape of themaze-type slot 452 may provide limited axial decoupling between theaxially moveable core 312 and the detachable implant 304 along the keyedportion 456 of the maze-type slot 452, such as described above withrespect to the slider assembly 400 of FIGS. 21-21E.

In another embodiment, the maze-type slot 452 of the bayonet mount 450is provided on the axially moveable core 312, and the flange 460 of thebayonet mount 450 is provided on the guide tube 320 of the sliderassembly 400. The flange 460 may extend in a radial outward direction,such as shown in FIG. 29C, or may extend in a radial inward direction,such as shown in FIG. 29G. In another embodiment, the flange 460 extendsin both radial outward and radial inward directions.

In other embodiments, a slider assembly need not be connected to theimplant, and for example, can be provided as part of the axiallymoveable core, or even the deployment handle in order to decouple axialmovement between the implant and delivery system. For example, in oneembodiment, an axially moveable core may include two concentric oraxially aligned tubes, slidably moveable with respect to one another,such as, for example, an outer tube and an inner tube. The outer tubemay include a mating surface on or near its distal end to engage amating surface on the distal hub, or elsewhere on the implant. The outertube slidably engages an inner tube, which enters the outer tube at theouter tube's proximal end. In one embodiment, a solid core is usedinstead of an inner tube. Relative proximal and distal movement of theinner and outer tube is preferably limited by a motion limit. In oneembodiment, the motion limit includes at least one cross pin. In otherembodiments, the motion limit includes at least one flare, annular ring,bump, or other suitable mechanism as is well known to those of skill inthe art. The inner tube extends preferably to a handle as describedabove for operating the axially moveable core. The engagement of theouter tube and the inner tube of the axially moveable core may occuranywhere between the handle and the implant along the length of thecore.

In another embodiment, the inner tube includes a mating surface on itsdistal end to engage a mating surface on the distal hub of the implant.The inner tube slidably engages an outer tube, which at least partiallycovers the inner tube at the inner tube's proximal end. Relativeproximal and distal movement of the inner and outer tube is preferablylimited by a motion limit as described above, with the outer tubeextending outside of the patient and operably connected to a handle.

In another embodiment as shown in FIGS. 29H-I, a first portion 462 ofthe axially moveable core 312, and a second portion 464 of the axiallymoveable core 312 are coupled to one another with a key mount 462. Thesecond portion 464 includes a flange 468, pin, or equivalent structure,which engages a maze-type slot 470 of the first portion 462 of theaxially moveable core 312. By pulling, rotating, and pushing the firstportion 462 with respect to the second portion 464 according to apredetermined sequence, limited axial decoupling between the firstportion 462 and second portion 464 is achieved.

In one embodiment, the first portion 462 comprises a proximal portion ofthe axially moveable core 312, and the second portion 464 comprises adistal portion of the axially moveable core 312. In another embodiment,the first portion 462 comprises a distal portion of the axially moveablecore 312, and the second portion 464 comprises a proximal portion of theaxially moveable core 312. In one embodiment, the flange 468 extends inan outward radial direction, such as shown in FIG. 29I. In anotherembodiment, the flange 468 extends in an inward radial direction, or inboth, radially outward and inward directions.

Alternatively, in another embodiment, a slider assembly can be providedas part of a deployment handle. In one embodiment, the distal portion ofan axially moveable core includes a mating surface to engage a matingsurface of the distal hub of the implant. The deployment handle caninclude a guide tube and an internally slideable nut, or other sliderassembly such as described above, for receiving the proximal end of theaxially moveable core.

FIG. 30 illustrates a deployment system 300, having an implant 304 and adelivery system 500, in accordance with one embodiment of the presentinvention. In a preferred embodiment, the implant 304 is atransluminally delivered device designed to occlude or contain particleswithin the left atrial appendage 502 (LAA 502) and prevent thrombus fromforming in, and emboli from originating from, the LAA 502. Thedeployment system as described herein incorporates a slider assembly 400such as described with respect to FIGS. 21-21E above.

The delivery system 500 preferably may be used to deliver the implant304 to occlude or block the LAA 502 in a patient with atrialfibrillation. The delivery system 500 preferably is compatible for usewith a delivery sheath 504 (e.g., a transseptal sheath), shown in FIGS.38A-38C. The delivery system 500 and implant 304 preferably are designedto allow the implant 304 to be positioned, repositioned, and retrievedfrom the LAA 502 if necessary. Injection ports 546, 548, as shown inFIGS. 32 and 33, preferably are provided in the delivery system 500 toallow contrast injection proximally and distally of the implant 304 tofacilitate in-vivo assessment of the positioning and seal quality of theimplant 304.

As shown in FIG. 31, the implant 304 preferably is available in a rangeof sizes to accommodate the anatomy of a patient's LAA 502. The implant304 preferably comprises a frame 506 and a membrane (not shown) on aproximal face of the implant, such as described above. The frame 506preferably is constructed of self-expanding nitinol supports. Themembrane preferably is constructed of a fabric covering, such as onemade of ePTFE, or an ePTFE/PE laminate. To attach the membrane to theframe 506, a PE mesh preferably is placed against the supports, with onesheet of ePTFE preferably placed over the PE mesh and another sheet ofePTFE preferably placed on an opposite side of the supports. Themembrane preferably is heated on both sides causing the PE to melt intoboth sheets of ePTFE, thereby surrounding a portion of the frame 506.The nitinol supports allow the implant 304 to self-expand in theappendage 502, covering the orifice with the laminated fabric. Theporous ePTFE/PE lamination facilitates rapid endothelialization andhealing.

As shown in FIGS. 30 and 31, the implant 304 preferably extends from aproximal end or hub 324 to a distal end or hub 314. In some embodiments,the proximal hub 324 is coupled with a crosspin 329 as described above.In some embodiments the distal hub 314 is coupled with a slider assembly400 as described above. The distal hub 314 preferably is coupled with animplant plug 316. In one embodiment, the implant plug 316 comprises anatraumatic tip, such that contact between the atraumatic tip and theinside surface of the LAA 502 does not cause significant damage to theLAA 502. The implant 304 preferably is expandable and collapsible. Theimplant 304 preferably comprises anchors 195 that extend from the frame506 when the implant 304 is expanded as described above.

As shown in FIGS. 32 and 33, the delivery system 500 preferablycomprises a peel-away sheath 512, a recapture sheath 514, a deploymentcatheter 516, and an axially moveable core 312, each described furtherbelow. In addition, FIG. 32 illustrates the deployment system without aloading collar 510, and FIG. 33 illustrates the deployment system with aloading collar 510, with the system operably connected to an implant304.

The deployment catheter 516, which is analogous to deployment catheter302 described above, preferably comprises a deployment handle 538 and amulti-lumen shaft 540. As shown in FIGS. 32 and 33, the deploymenthandle 538 preferably comprises a control knob 542, a release knob 544,a proximal injection port 546 and a distal injection port 548. Themulti-lumen shaft 540 preferably comprises a four-lumen shaft shown inFIG. 32A. The multi-lumen shaft 540 preferably comprises a core lumen550 for holding an axially moveable core 312, a control line lumen 552and two proximal injection lumens 554 in communication with proximalinjection port 546.

An axially moveable core 312 preferably extends from the deploymenthandle 538 through the core lumen 550 of the catheter 516 and couplesthe implant 304 to the delivery system 500 through a slider assembly 400as described above. Referring to FIGS. 30, 33 and 36, a control line 328(referred to previously as a pull wire 328) preferably extends throughthe control line lumen 552 and preferably couples a proximal hub 324 ofthe implant 304 to the deployment handle control knob 542, allowing forimplant 304 expansion and collapse. The control line 328 preferablyextends around a portion of the axially movable core 312 near theproximal hub 324 of the implant 304, and is coupled to the implant 304by crosspin 329, as described above.

As shown in FIG. 36 (which is similar to FIG. 21), the deploymentcatheter 516 preferably comprises a flexible catheter section 562 at itsdistal end, which in some embodiments is a spiral cut tubular sectionhoused in a polymer sleeve 566. The flexible catheter section 562 may becoupled to a distal end of multilumen shaft 540.

As shown in FIGS. 36 and 37, the axially moveable core 312 preferablyincludes a hollow proximal shaft 576 and a hollow distal shaft 578 witha flexible hollow core section 564 therebetween, all co-axially alignedand connected. In one embodiment, the proximal end of the distal shaft578 is attached to the distal end of the flexible core section 564, andthe proximal end of the flexible core section 564 is attached to thedistal end of the proximal shaft 576. In some embodiments, the flexiblecore section 564 has a spring coil section 568 housed in a polymersleeve 570, the spring coil section 568 preferably coupled with theshafts 576 and 578 on first and second ends 572, 574.

The axially moveable core 312 preferably is disposed within thedeployment catheter 516 such that the flexible core section 564 may belinearly co-located with the flexible catheter section 562 at a distalportion 560 of the delivery system 500 during appropriate times during aprocedure, as shown in FIG. 36. When the flexible core section 564 isaligned and linearly co-located with the flexible catheter section 562,the sections preferably cooperate to form a delivery system flexiblesegment 558. As shown in FIGS. 32, 33, and 36, the delivery systemflexible segment 558 preferably is located toward a distal end 560 ofthe delivery system 500.

In one embodiment, shown in FIG. 37, the distal shaft 578, flexible coresection 564, and proximal shaft 576 are attached by welding. Smallwindows 580 may be provided to allow welding materials to flow betweenthe shafts 564, 576 and 578 and provide stronger bonding therebetween.In another embodiment, solder, glue, or press-fitting is used to attachshafts 564, 576, and 578 to one another, as is well known to those ofskill in the art. In another embodiment, the shafts 564, 576 and 578 areformed from a single tube, for example, a laser-cut tube. In otherembodiments, more than one tube may be used to form each of the shafts564, 576 and 578. For example, FIG. 37 illustrates proximal shaft 576comprising two tubes connected by welding such as described above.

Referring to FIG. 37A, distal contrast media preferably can be injectedthrough a lumen 582 in the shafts 576 and 578 for determining theplacement of the implant 304. This lumen may be in fluid communicationwith distal injection port 548, shown in FIGS. 32 and 33. The distalshaft 578 preferably comprises a mating surface 584 and a radiopaquemarker 586, such as described above. In one embodiment, the matingsurface 584 is a threaded surface. The distal shaft 578 preferably isreleasably coupled through the implant 304 with the slider assembly 400,such as described above.

When the delivery system 500 is assembled, the recapture sheath 514 ispreferably loaded over the deployment catheter 516, distal to the handle538, as shown in FIGS. 32 and 33. The recapture sheath 514 preferably isdesigned to allow recapture of the implant 304 prior to its finalrelease such as described with respect to retrieval catheter 360 above.Recapture petals or flares 528 preferably are provided on the distal end530 of the recapture sheath 514 to cover the anchors 195 of the implant304 during retrieval into the delivery sheath 504, as described abovewith respect to FIGS. 20A-20C, and further below. A Touhy-Borst adapteror valve 532 preferably is attached to the proximal end 534 of therecapture sheath 514. The recapture sheath 514 preferably comprises aradiopaque marker 536 on its distal end 530 near the recapture flares528. The recapture sheath 514 preferably comprises a recapture sheathinjection port 588 for delivering fluid proximal the implant 304.

The peel-away sheath 512 preferably is provided over a portion of therecapture sheath 514, between Touhy-Borst valve 532 and recapture flares528. The peel-away sheath 512 preferably is used to introduce thedelivery system 500 into a delivery sheath 504 shown in FIGS. 38A-38C,described below. As shown in FIGS. 32 and 33, the peel-away sheath 512preferably comprises a locking collar 522, a peel-away section 524, anda reinforced section 526. The locking collar can be unlocked relative topeel-away section 524, and preferably includes a threaded hub 523 thatreleasably engages tabs 525 of the peel-away section 524.

The loading collar 510 preferably is located over a portion of thepeel-away sheath 512 and a portion of the recapture sheath 514 with itsproximal end being located over the peel-away sheath 512 at its distalend loaded over recapture sheath 514. The loading collar 510 preferablyaccommodates loading a collapsed implant 304 into the peel-away sheath512 as described below. As shown in FIGS. 33 and 34, the loading collar510 preferably comprises a first end portion 518 adapted to receive andextend over a collapsed implant 304, and a second end portion 520configured to guide the collapsed implant 304 into the peel-away sheath512. The loading collar 510 preferably is made of stainless steel.

To assemble the delivery system, the axially movable core 312 andcontrol line 328 preferably are fed into the multi-lumen shaft 540 ofthe deployment catheter 516. The multi-lumen shaft 540 preferably isthen coupled with components of the deployment handle 538 and theinjection port components 546, 548. The peel-away sheath 512 and theloading collar 510 preferably are slid onto the recapture sheath 514,and the recapture sheath 514 is slid onto the deployment catheter 516.The implant 304 preferably is then loaded on an end of the axiallymovable core 312 and coupled with the control line 328. In oneembodiment, the implant 304 is loaded on an end of the axially movablecore 312 by screwing the axially movable core 312 into the slider nut402 of the slider assembly 400. The control knob 542 and outer casing ofthe deployment handle 538 preferably are then coupled with the system.

The deployment system 300 preferably is used in connection with adelivery sheath 504 to advance the implant 304 for deployment in apatient. As shown in FIGS. 30 and 38A-38C, the delivery sheath 504 is atubular device that in one embodiment can be advanced over a guidewire(not shown) for accessing the LAA 502 of a patient. Delivery sheath 504in one embodiment has a permanent bend 594, as shown in the views ofFIGS. 38A and 38B. A hemostasis valve 596 is provided at the proximalend of transseptal sheath. A fluid injection port 598 is also providedat the proximal end to deliver fluid such as contrast media through thetransseptal sheath. Systems and methods for implanting the device 304 inthe LAA 502 are described further below.

In one embodiment, the system and method preferably allows for accessand assessment of the LAA 502. A guidewire (not shown) preferably isused to access the superior or inferior vena cava through groin access.For example, a delivery sheath 504 preferably is advanced over theguidewire and into the superior vena cava. The guidewire preferably isremoved and replaced with a transseptal needle (not shown). The deliverysheath 504 preferably is retracted inferiorly so that the bend 594 indelivery sheath directs the distal tip of the delivery sheath 504 towardthe fossa ovalis. The needle preferably is advanced to puncture thefossa ovalis. The delivery sheath 504 preferably is advanced toestablish access to the LAA 502 and the needle preferably is retracted.Further details or disclosure are provided in copending U.S. patentapplication Ser. Nos. 09/435,562 and 10/033,371, the entireties of whichare hereby incorporated by reference. In one embodiment, the implant 304can be deployed within the LAA 502 as an adjunct to surgical heartprocedures, as described below. The delivery sheath 504 for establishingaccess to the LAA 502 can be generally straight and can have a lengthless than the length of the delivery sheath 504 which is advancedthrough the superior or inferior vena cava.

After properly preparing a delivery sheath 504 for LAA 502 access, thesize of the neck diameter and morphology of the LAA 502 preferably isdetermined by advancing the delivery sheath 504 to the distal portion ofthe LAA 502 and injecting contrast media to obtain an initial leftatrial appendogram. The neck diameter preferably is measuredapproximately 5 mm in from the ostium of the LAA 502 at end diastole.

In one embodiment, the system and method preferably allows for selectionand preparation of a deployment system 300. A deployment system 300preferably comprises an implant 304 of an appropriate size for placementin a patient. Initially, the implant 304 preferably is in an expandedconfiguration, with axially moveable core 312 engaging slider assembly400, as described above. The recapture sheath 514 preferably ispositioned so it covers and supports the flexible segment 558 of thedelivery system 500, wherein the flexible catheter section 562 ofdeployment catheter 302 and flexible core section 564 of axiallymoveable core 312 are aligned. The Touhy-Borst valve 532 preferably istightened over the deployment catheter 516 to prevent relative movementbetween recapture sheath 514 and deployment catheter 516. The loadingcollar 510 and peel-away sheath 512 preferably are positioned so theyare at the base of the recapture flares 528, proximal thereto.

The delivery system 500 preferably is loaded by rotating the controlknob 542 counterclockwise until the implant 304 is fully collapsed.Preferably, at least a portion of the control line 328 is coupled withthe control knob 542 such that rotation of the control knob 542 in thecounterclockwise direction retracts at least a portion of the controlline 328. Retraction of the control line 328 preferably places tensionon the proximal hub 324 of the implant 304, because a portion of thecontrol line 328 preferably is coupled with the proximal hub 324 by apin 329. While the distal portion of the axially moveable core 312engages slider assembly 400 and applies a distal force to distal hub 314of the implant 304, tension in the control line 328 preferably causesthe proximal hub 324 of the implant 304 to move proximally relative theaxially moveable core 312, thereby collapsing the implant 304.

The diameter of the implant 304 preferably is reduced to approximately⅓.sup.rd or less of its original diameter when collapsed. The loadingcollar 510 and peel-away sheath 512 are then advanced distally over theflares 528 and implant 304 until the distal tip of the implant 304 isaligned with the distal end of the peel-away sheath 512 and the distalend of the loading collar is about 1.5 cm from the distal tip of theimplant At this point, the flares 528 partially cover the implant. Theloading collar 510 preferably is removed and discarded.

With the implant 304 partially within the recapture sheath 514 andretracted within the peel-away sheath 512, the entire system preferablyis flushed with sterile heparinized saline after attaching stopcocks tothe recapture sheath injection port 588, the proximal injection port 546and distal injection port 548 of the delivery system 500. The recapturesheath 514 and the Touhy-Borst valve 532 are first thoroughly flushedthrough port 588. Then the distal injection port 548 and the proximalinjection port 546 of the deployment handle 538 are preferably flushedthrough. The distal injection port 548 is in fluid communication withlumen 426 of axially moveable core 312, and proximal injection port 546is in fluid communication with injection lumens 554 of multilumen shaft540. The delivery sheath 504 placement preferably is reconfirmed usingfluoroscopy and contrast media injection.

The delivery system 500, as described above, with implant 304 insertedtherein, preferably is then inserted into the proximal end of thedelivery sheath 504. To avoid introducing air into the delivery sheath504 during insertion of the delivery system 500, a continual, slow flushof sterile heparinized saline preferably is applied through the proximalinjection port 546 of the deployment handle 538 to the distal end of thedeployment catheter 516 until the tip of the peel-away sheath 512 hasbeen inserted into, and stops in, the hemostatic valve of the deliverysheath 504. Preferably, the distal tip of the peel-away sheath 512 isinserted approximately 5 mm relative to the proximal end of the deliverysheath 504.

Under fluoroscopy, the recapture sheath 514 and deployment catheter 516preferably are advanced, relative to the peel-away sheath 512,approximately 20-30 cm from the proximal end of the transseptal sheath,and the system 500 preferably is evaluated for trapped air. Thepeel-away sheath 512 is preferably not advanced into the delivery sheath504 due to the hemostasis valve 596 blocking its passage. If air ispresent in the system 500, it may be removed by aspirating through thedistal injection port 548, recapture sheath injection port 588, orproximal injection port 546. If air cannot be aspirated, the deploymentcatheter 516 and recapture sheath 514 preferably are moved proximallyand the delivery system 500 preferably is removed from the deliverysheath 504. All air preferably is aspirated and theflushing/introduction procedure preferably is repeated.

The peel-away sheath 512 preferably is manually slid proximally to theproximal end 534 of the recapture sheath 514. The Touhy-Borst valve 532preferably is loosened and the deployment catheter 516 preferably isadvanced distally relative to the recapture sheath 514 until thedeployment handle 538 is within about 2 cm of the Touhy-Borst valve 532of the recapture sheath 514. This causes the implant 304 to be advanceddistally within the delivery sheath 504 such that the recapture sheath514 no longer covers the implant 304 or the flexible section 558. TheTouhy-Borst valve 532 preferably is tightened to secure the deploymentcatheter 516 to fix relative movement between the deployment catheter516 and recapture sheath 514.

Under fluoroscopy, the implant 304 preferably is advanced to the tip ofthe delivery sheath 504 by distal movement of the delivery catheter 302.The distal hub 314 of implant 304 preferably is aligned with a deliverysheathtip radiopaque marker 590. Under fluoroscopy, the sheath 504positioning within the LAA 502 preferably is confirmed with a distalcontrast media injection.

The position of the implant 304 preferably is maintained by holding thedeployment handle 538 stable. The delivery sheath 504 preferably iswithdrawn proximally until its tip radiopaque marker 590 is aligned withthe distal end of the deployment catheter flexible segment 558. Thispreferably exposes the implant 304.

Under fluoroscopy, the implant 304 preferably is expanded by rotatingthe control knob 542 clockwise until it stops. Rotating the control knob542 preferably releases tension on the control line 328, preferablyallowing the implant 304 to expand. The implant 304 preferably isself-expanding. After expansion, any tension on the LAA 502 preferablyis removed by carefully retracting the deployment handle 538 underfluoroscopy until the radiopaque marker 586 on the axially movable core312 moves proximally approximately 1-2 mm in the guide tube 320. Theposition of the implant 304 relative the LAA 502 preferably is notaltered because the axially movable core 312 preferably is coupled withthe slider assembly 400 allowing for relative movement between theimplant 304 and the axially movable core 312. The slider assembly 400preferably allows for the distal portion of the axially movable core 312to be slightly retracted proximally from the distal hub 314 of theimplant 304, thereby removing any axial tension that may be acting onthe implant 304 through the axially movable core 312. The radiopaquemarker 586 preferably is about 1-2 mm proximal from the implant 304distal hub 314, and the delivery sheath 592 tip preferably is about 2-3mm proximal from the implant proximal hub 324, thereby indicating aneutral position.

Under fluoroscopy, the expanded diameter (.O slashed. in FIG. 30) of theimplant 304 preferably is measured in at least two views to assess theposition of the implant within the LAA 502. The measured implantdiameter .O slashed. preferably is compared to the maximum expandeddiameter.

Preferably, the labeled proximal and distal injection ports 546, 548 ofthe deployment handle 538 shown in FIG. 32, correlate with the proximaland distal contrast media injections. The proximal contrast mediainjections are delivered through the delivery catheter lumen 554 to alocation proximal to the implant 304. The distal contrast mediainjections are delivered through the axially movable core 312 to alocation distal to the implant 304. Proximal contrast media injectionspreferably are completed in two views. If the injection rate isinsufficient, the recapture sheath injection port 588 may be usedindependently or in conjunction with the proximal injection port 546 todeliver fluid to a location proximal to the implant 304.

If satisfactory results are seen, any transverse tension on the LAA 502preferably is released by exposing the flexible segment 558 of thedelivery system 500. The flexible catheter section 562 and the flexiblecore section 564 preferably are linearly co-located to cooperate as theflexible segment 558 of the delivery system 500. This preferably isaccomplished by retracting the delivery sheath 504 proximallyapproximately 2 cm to expose the flexible segment. By exposing theflexible segment 558, the flexible segment 558 preferably will flex toallow the implant 304 to sit within the LAA 502 free from transverseforces that may be created, for example, by contractions of the heartacting against the delivery sheath 504 or deployment catheter 516.

Once the flexible segment 558 is exposed, distal contrast mediainjections preferably are completed in at least two views to verifyproper positioning of the implant 304. A flush of saline preferably isused as needed between injections to clear the contrast media from theLAA 502. Following the contrast media injections, the delivery sheath504 preferably is advanced distally to cover the flexible segment 558.

If implant 304 position or results are sub-optimal, the implant 304preferably may be collapsed and repositioned in the LAA 502. To achievethis, under fluoroscopy, the deployment handle 538 preferably isadvanced distally to place the radiopaque marker 586 of the axiallymoveable core 312 at the distal hub 314 of the implant 304. The distalend of the delivery sheath 504 preferably is aligned with the distal endof the flexible segment 558. The control knob 542 preferably is rotateduntil the implant 304 has been collapsed to approximately ⅓.sup.rd orless of its expanded diameter. The control knob 542 preferably acts onthe control line 328 to place tension on the proximal hub 324 of theimplant 304, pulling the proximal hub 324 of the implant 304 proximallyrelative the distal hub 314 of the implant 304 to collapse the implant304. The implant 304 preferably can be repositioned and re-expanded.

The stability of the implant 304 preferably is verified in severalviews. Stability tests preferably are preformed in the following manner.A contrast media filled syringe preferably is connected to the distalinjection port 548 of the deployment handle 538. Under fluoroscopy, atleast about a 10 mm gap between the tip of the delivery sheath 504 andthe proximal hub 222 of the implant 304 is preferably confirmed.

The stability of the implant 304 in the LAA 502 preferably is evaluatedusing fluoroscopy and echocardiography. The recapture sheath Touhy-Borstvalve 532 preferably is loosened. Then the deployment handle 538preferably is alternately retracted and advanced about 5-10 mm whilemaintaining the position of the delivery sheath 504 and simultaneouslyinjecting contrast media through the distal injection port 548. Thistests how well the implant is held within the LAA 502.

If the implant stability tests are unacceptable, the implant 304preferably may be collapsed and repositioned as described above. Ifrepositioning the implant 304 does not achieve an acceptable result, theimplant 304 preferably may be collapsed and recaptured as describedfurther below.

The implant 304 preferably meets the following acceptance criteria,associated with the assessment techniques listed below, prior to beingreleased. The assessment techniques to be evaluated preferablyinclude 1) residual compression; 2) implant location; 3) anchorengagement; 4) seal quality; and 5) stability. For residual compression,the implant diameter .O slashed., as measured by fluoroscopic imaging,preferably is less than the maximum expanded diameter of the implant304. For implant location, the proximal sealing surface of the implant304 preferably is positioned between the LAA 502 ostium and sources ofthrombus formation (pectinates, secondary lobes, etc.) (preferablyimaged in at least two views). For anchor engagement, the implant frame506 preferably is positioned within the LAA 502 so as to completelyengage a middle row of anchors 195 in an LAA 502 wall (preferably imagedin at least two views). For seal quality, the contrast injectionspreferably show leakage rated no worse than mild (preferably defined asa flow of contrast media, well defined, and filling one-third of the LAA502 during a proximal injection over a period of up to about fiveventricular beats, preferably imaged in at least two views). Forstability, there preferably is no migration or movement of the implant304 relative to the LAA 502 wall as a result of the Stability Test.

If implant recapture is necessary, because a different size implant 304is necessary or desired, or if acceptable positioning or sealing cannotbe achieved, the implant 304 preferably is fully collapsed as describedabove. Once the implant 304 is collapsed, the locking collar 522 of thepeel away sheath 512 preferably is unlocked. The peel-away portion 524of the peel-away sheath 512 preferably is split up to the reinforcedsection 526 and removed. The reinforced section 526 of the peel-awaysheath 512 preferably is slid proximally to the hub of the recapturesheath 514. The Touhy-Borst valve 532 on the proximal end of therecapture sheath 514 preferably is slightly loosened to allow smoothmovement of the sheath 514 over deployment catheter 516 without allowingair to enter past the Touhy-Borst valve 532 seal. By removing thepeel-away portion 524 of peel-away sheath 512, the recapture sheath 514can now be advanced further distally relative to the transseptal sheath.

While holding the deployment catheter 516 and delivery sheath 504 inplace, the recapture sheath 514 preferably is advanced distally into thedelivery sheath 504 until a half marker band 536 on the recapture sheath514 is aligned with a full marker band 590 on the delivery sheath 504.This preferably exposes the recapture flares 528 outside the transseptalsheath.

The collapsed implant 304 preferably is retracted into the recapturesheath 514 by simultaneously pulling the deployment handle 538 andmaintaining the position of the recapture sheath 514 until approximatelyhalf the implant 304 is seated in the recapture sheath 514. TheTouhy-Borst valve 532 on the recapture sheath 514 preferably istightened over the deployment catheter 516. The recapture sheath 514 andimplant 304 preferably are retracted into the delivery sheath 504 bypulling on the recapture sheath 514 while maintaining the position ofthe delivery sheath 504, preferably maintaining left atrial access. Therecapture flares 528 of the recapture sheath 514 preferably cover atleast some of the anchor elements 195 on the implant 304 as the implantis retracted proximally into the delivery sheath 504. Further detailsare described above with respect to FIGS. 20A-20C.

If the implant's position and function are acceptable, and implantrecapture is not necessary, the implant 304 preferably is released fromthe delivery system 500. Under fluoroscopy, the delivery sheath 504preferably is advanced to the proximal hub 324 of the implant 304 forsupport. The release knob 544 on the proximal end of the deploymenthandle 538 preferably is rotated to release the implant 304. Rotatingthe release knob 544 preferably causes a threaded portion 584 of thedistal shaft 578 of the axially movable core 312 to rotate with respectto the slider assembly 400 such that the threaded section 584 preferablyis decoupled from the slider assembly 400. Under fluoroscopy, after theaxially movable core 312 is decoupled from the implant 304, the releaseknob 544 preferably is retracted until the distal end 578 of the axiallymovable core 312 is at least about 2 cm within the delivery sheath 504.

Under fluoroscopy, while assuring that transseptal access is maintained,the delivery system 500 preferably is retracted and removed through thedelivery sheath 504. Under fluoroscopy, the delivery sheath 504 positionpreferably is verified to be approximately 1 cm away from the face ofthe implant 304. Contrast injections, fluoroscopy and/orechocardiography preferably may be used to confirm proper positioningand delivery of the implant 304 and containment of the LAA 502. Thedelivery sheath 504 preferably is withdrawn.

In addition to the aforementioned techniques, an implant as describedabove can be delivered, e.g., using conventional transthoracic surgical,minimally invasive, or port access approaches. Delivery can be made ordone in conjunction with surgical procedures. Implant 304, for example,can be used in conjunction with various surgical heart proceduresrelated to the heart (e.g., mitral valve repair) or surgical proceduresin the region surrounding the heart. The delivery system 500 anddelivery sheath 504 can be used to locate and deploy the implant 304 inorder to prevent the passage of embolic material from the LAA, such thatthrombus remains contained in the LAA 502. Thrombus remains contained inthe LAA 502 because the implant 304 inhibits thrombus within the LAA 502from passing through the orifice of the LAA 502 and into the patient'sblood stream. Additionally, the deployed implant 304 located in the LAA502 can provide a smooth, non-thrombogenic surface facing the leftatrium. Preferably, the smooth, non-thrombogenic surface facing the leftatrium will not promote blood clots to form proximate to the LAA 502.Access to the heart may be provided by surgical procedures in order todeploy the implant 304 in the LAA 502. That is, the implant 304 can bedeployed as an adjunct to surgical procedures. Access to the left atriumis provided in one embodiment by obtaining a left atrium access path.The delivery sheath 504 can be located along the left atrium access pathto define a delivery path. The delivery system 500 can be used todeliver the implant 304 along the delivery path to a position fordeployment. The implant 304 located in the position for deployment canbe deployed to block the LAA 502. There are many methods of deliveringand deploying the implant 304 as described in further detail below.

In particular, access to the heart of a patient can be provided byvarious techniques and procedures so that implant 304 can delivered anddeployed in the heart. For example, minimally invasive surgerytechniques, laparoscopic procedures and/or open surgical procedures canprovide the left atrium access path to the heart. In one embodiment,access to the LAA can be provided by access through the chest of thepatient, and may include, without limitation, conventional transthoracicsurgical approaches, open and semi-open heart procedures, laparoscopic,and port access techniques. Such surgical access and procedurespreferably will utilize conventional surgical instruments for accessingthe heart and performing surgical procedures on the heart, for example,retractors, rib spreaders, trocars, laparoscopic instruments, forceps,scissors, shears, rongeurs, clip appliers, staplers, sutures, needleholders, bulldogs, clamps, elevators, cauterizing instruments orsubstances, electrosurgical pens, suction apparatuses, approximators,and/or the like. The implant can be conveniently deployed as an adjunctto a surgical heart procedure, such that the implant can be delivered atthe LAA without performing additional complicated procedures for gainingaccess to the LAA. As used herein the phrase “surgical heart procedure”is a broad phrase and is used in accordance with its ordinary meaningand may include, without limitation, open procedures, semi-openprocedures, laparoscopic procedures, open heart surgery and may includeprocedures for replacing and/or repairing portions of the heart. In onenon-limiting exemplifying embodiment, surgical heart procedures includetreatment of the heart, such as aortic valve repair, mitral valverepair, pulmonary valve repair, and/or replacement of a heart valve(e.g., a diseased aortic, mitral, or pulmonary valve) with an artificialvalve or prosthesis. The known conventional surgical instruments foraccessing the heart and performing surgical procedures on the heart canbe used in combination with instruments used for these heart treatments.For example, sizing rings, balloons, calipers, gages, and the like canbe employed to match an implant/device (such as artificial valve orprosthesis) to an anatomical structure of the heart.

Many times, the access techniques and procedures can be performed by thesurgeon and/or a robotic device, such as robotic systems used forperforming minimally invasive heart surgery. Those skilled in the artrecognize that there are many different ways the heart can be accessed.

In one embodiment, the access to the left atrium can be obtained bycreating a left atrium access path. The left atrium access path is apath the can be used to locate the delivery sheath into a patient's bodyfor implant 304 delivery. The left atrium access path can be obtainedbefore, during, or after another surgical heart procedure (e.g., mitralvalve repair), which many times can provide the left atrium access path.The left atrium access path can be sized to allow the passing of thedelivery sheath 504 along the left atrium access path without injuringthe patient. The techniques and procedures for obtaining the left atriumaccess path can be performed by the surgeon and/or a robotic device.

The left atrium access path can be disposed in various locations in thepatient's body. For example, the left atrium access path can be locatedwithin the pulmonary vein and to the left atrium. In another embodiment,the left atrium access path can be located outside of the heart andthrough the wall of the left atrium and into the left atrium. In anotherembodiment, the left atrium access path is located within the rightatrium through a transseptal puncture and passes into the left atrium.In another embodiment, the left atrium access path is located through anopening, for example obtained during an open heart procedure, in thewall of left atrium and into the left atrium. Those skilled in the artrecognize that the left atrium access path can be located in variousother positions.

The delivery sheath 504 can be positioned along the left atrium accesspath and can define a delivery path for the delivery of the implant 304.The delivery path is disposed within and along the delivery sheath 504.The delivery sheath 504 is sized to permit the implant 304 to pass alongthe delivery path through the delivery sheath 504 and out of a distalend 702 of the delivery sheath 504 (as shown in FIG. 30). The deliverysheath 504 can be configured for particular left atrium access paths,which are described herein. The delivery sheath 504, of course, can beused with the delivery system 500 and 300, as described above.

In the illustrated embodiment of FIG. 40, the implant 304 can bedelivered along a delivery path 901 that passes through the pulmonaryvein 904 and through the left atrium to the LAA 502, e.g., the distalend 702 of the delivery sheath 504 can be positioned for delivery anddeployment of the implant 304. The delivery path 901 can be positionedby inserting the distal end 702 of the delivery sheath 504 into thepulmonary vein 904 and advancing the distal end 702 of the deliverysheath 504 along the pulmonary vein 904 towards the wall of the leftatrium. The sheath 504 can be delivered to the pulmonary vein, forexample, in a surgical heart procedure, such as in conventional openprocedure through the chest of a patient, or in a laparoscopic approachthrough the chest using trocars and other instruments to direct thedelivery sheath 504 to the pulmonary vein. The distal end 702 of thedelivery sheath 504 can pass through the chamber of the left atrium suchthat the distal end 702 of the delivery sheath 504 is proximate to theorifice of the LAA 502. The implant 304 can be delivered through thedelivery sheath 504 and along the delivery path 901 as indicated by thearrows. Thus, the delivery sheath 504 defines the delivery path 901 thatpasses through the pulmonary vein 904, the chamber of the left atrium,and is used to deliver the implant 304 to the LAA 502. Delivery anddeployment of the implant 304 can be accomplished using the techniquesas described above, or other suitable techniques. In some non-limitingexemplifying embodiments, the delivery sheath 504 has length that isgreater than about 15 cm. In some non-limiting exemplifying embodiments,the delivery sheath 504 has a length of about 50 cm or less, and evenmore preferably about 45 cm or less, about 40 cm or less, about 35 cm orless, about 30 cm or less, about 25 cm or less, about 20 cm or less,about 15 cm or more, or even ranges encompassing such lengths. Thedelivery sheath 504 can have a length suitable for allowing the surgeonto easily position the delivery sheath 504 through the pulmonary vein(or along other delivery paths described below). For example, in an openprocedure, one hand of the surgeon can position the delivery sheath 504in the heart and the other hand of the surgeon can hold and position theproximal end of delivery sheath 504 outside of chest cavity. Thus, aperson can manually position the delivery sheath 504 to deliver theimplant into the LAA. Many times, conventional sheaths are long andtherefore awkward to stabilize and may be difficult to position bothends of the conventional sheath. Alternatively, the delivery sheath 504can be positioned by a robotic system, multiple surgeons, and/or othersuitable means for positioning.

In the illustrated embodiment of FIG. 41, the implant 304 can bedelivered along a delivery path 910 that passes directly through anopening 912 in the wall of the left atrium. In some embodiments, theopening 912 is formed in an outer wall 913 of the left atrium. The outerwall 913 forms a portion of the outer surface 915 of the heart. Theopening 912 is preferably spaced from the LAA 502 so that the deliverysheath 504 can be easily positioned near the LAA 502. For example, theopening 912 can be spaced from the orifice of the LAA 502 by a distanceof about 1 to 10 cm, more preferably about 5 cm. However, the opening912 can be formed at any point along the outer wall 913. For example,the opening 912 can be formed in the wall of the LAA 502. The opening912 is configured and sized to receive the delivery sheath 504. In someexemplifying non-limiting embodiments, the cross sectional area of thedelivery sheath 504 is equal to or more than about 30% of the area ofthe opening 912. The cross-sectional area of the delivery sheath 504 canbe equal to or more than 40%, 50%, 60%, 70%, 80%, 90%, and rangesencompassing such percentages of the area of the opening 912. Thus, thedelivery sheath 504 can be conveniently inserted through the opening 912and maneuvered within the left atrium.

The illustrated delivery path can be positioned by passing the distalend 702 of the delivery sheath 504, which is located outside of theheart, through the wall 913 of the left atrium and into the chamber ofthe left atrium. It will be appreciated that the sheath 504 may besteered or turned to the desired location. The delivery sheathpreferably has a length suitable for accessing the opening 912 and theLAA 502 from outside the heart and outside the patient, more preferablyabout 80 cm or less, and even more preferably about 70 cm or less, about50 cm or less, about 30 cm or less, about 10 cm or less, or even rangesencompassing these lengths. As discussed above, the surgeon can easilyposition the delivery sheath 504. The delivery sheath 504 is distallyadvanced to a position for deployment, such that the distal end 702 ofthe delivery sheath 504 is proximate to the orifice of the LAA 502. Theimplant 304 can be delivered through the delivery sheath 504 and alongthe delivery path 910 as indicated by the arrows. Thus, the deliverysheath 504 defines the delivery path that passes directly through thewall of the left atrium and is used to deliver the implant 304 to theLAA 502.

In the illustrated embodiment of FIG. 42, the implant 304 can bedelivered along a delivery path 920 that passes through the rightatrium, a transseptal puncture 930, and the left atrium. The deliverypath can be positioned by passing the distal end 702 of the deliverysheath 504 through the right atrium and towards the transseptal puncture930. The transseptal puncture is sized and located to allow the distalend 702 of the delivery sheath 504 to pass through the transseptalpuncture 930 and into the left atrium. The distal end 702 of thedelivery sheath 504 is moved proximate to the orifice of the LAA 502 forthe delivery and deployment of implant 304 by distally advancing thedelivery sheath 504 through the right atrium and the transseptalpuncture 930. The implant 304 can be delivered through the deliverysheath 504 and along the delivery path 920 as indicated by the arrows.Thus, the delivery sheath 504 defines a delivery path that passesthrough the right atrium, the transseptal puncture 930, and the leftatrium. Access can be gained to the right atrium, for example, throughthe superior vena cava (as discussed above) or through the inferior venacava. Access to the right atrium through the inferior vena cava can beobtained by advancing the delivery sheath 504 over the guidewiredisposed within the inferior vena cava and the right atrium. Thus, thedelivery sheath 504 can define a delivery path 920 that passes throughthe superior or inferior vena cava, the right atrium, and thetransseptal puncture 930 and into the left atrium. Alternatively, thedelivery path can comprise a pre-existing septal defect such as a hole(an atrial septal defect) or a tunnel (a patent foramen ovale).

As discussed above, the delivery sheath 504 can have variousconfigurations that facilitate the delivery and deployment of theimplant 304. For example, the delivery sheath 504 used for defining thedelivery path through the pulmonary vein and the left atrium may havedifferent shape and size than the delivery sheath 504 used for defininga delivery path directly through the wall of the left atrium. Inparticular, the length of the delivery sheath 504, which is used bypassing the delivery sheath 504 through the pulmonary vein, may bedifferent than the length of the delivery sheath 504, which is used bypassing the delivery sheath 504 through the wall of the left atrium.Thus, the configuration of the delivery sheath 504 can ensure that theimplant 304 can be delivered to the proper location in the heart eventhough a plurality of left atrium access paths can be used to deliverthe implant 304 to the LAA 502. The delivery sheath 504 can have variouscross sectional profiles, curves, shapes and sizes to ensure that theimplant 304 can be properly delivered and deployed. For example, adistal portion of the delivery sheath 504 can be configured to deliverthe implant 304 within the LAA 502. Preferably, the distal portion ofthe delivery sheath 504 can be configured (e.g., having pre-shaped orpermanent curves) in order to locate the distal end 702 of the deliverysheath 504 within the LAA 502. The curvature of the distal end 702 ofdelivery sheath 504 can be similar to the curvature of the LAA 502 suchthat the distal end 702 can be distally advanced within the LAA 502.Further, the distal portion of the delivery sheath 504 can be anatraumatic soft-tip to prevent injury to the patient.

As shown in FIG. 39, a transition catheter or member 704 can be usedwith the delivery sheath 504 for easy handling and preventing injuries.The transition catheter 704 can be disposed within the delivery sheath504 so that distal end 702 of the delivery sheath 504 is proximate tothe distal end of the transition catheter 704. While the transitioncatheter 704 is disposed within the delivery sheath 504, the deliverysheath 504 can be put into the patient to define the delivery path forthe implant 304. In one embodiment, the distal end of the transitioncatheter 704 can be a smooth, round top. The smooth, round top canprevent damage to the distal end 702 of the delivery sheath 504, forexample, by providing structural support to the distal end 702 of thedelivery sheath 504. Additionally, the smooth, round top can preventinjury to the patient by providing an atraumatic surface that contactsthe patient thereby preventing contact between the distal end 702. Afterthe delivery sheath 504 is properly located, the transition catheter 704can be removed from the delivery sheath 504. Then the implant 304 can beinserted into the sheath 504 and delivered, as described above.

In one embodiment, the delivery sheath 504 can be advanced over aguidewire, not shown, for accessing the LAA 502 of a patient. Forexample, the guidewire can be disposed directly through the wall of theleft atrium, e.g., along a left atrium access path through the wall ofthe left atrium. The delivery sheath 504 can be advanced over theguidewire and directly through the wall of the left atrium and towardsthe LAA 502. Additionally, the positioning of the delivery sheath 504can be aided by various techniques, such as direct visualization fromthe exterior surface of the heart, visualization through the use ofechocardiography (e.g., Intracardiac Echo or Transsesophogeal Echo),visualization through optics including through thoracoscopes, or throughthe use of X-Ray fluoroscopy. These techniques can aid the surgeon toproperly advance and locate the delivery sheath 504.

After the delivery sheath 504 is in the desired position, the implant304 can be deployed as described above. Generally, once the deliverysheath 504 is in deployment position, the delivery catheter 360 can beinserted into the delivery sheath 504. The delivery catheter has anappropriate length corresponding to the length of the delivery sheath,as selected for a desired access technique. For example, in a procedurethrough the wall of the left atrium or in an open procedure, asdescribed herein, the delivery catheter, like the delivery sheath, mayhave a length of about 110 cm or less, and even more preferably about 80cm or less, about 50 cm or less, about 30 cm or less, or even about 20cm or less. In some embodiments, the delivery catheter has a length thatis slightly greater than the delivery sheath. For example, the deliverycatheter can have a length that is about 10 cm to about 30 cm greaterthan the length of the delivery sheath. For example, the deliverycatheter can have a length that is about 10 cm greater than the lengthof the delivery sheath, about 15 cm greater than the length of thedelivery sheath, about 20 cm greater than the length of the deliverysheath, about 25 cm greater than the length of the delivery sheath,about 30 cm greater than the length of the delivery sheath, and rangesencompassing these lengths. The implant 304 is collapsed and then theloading collar 510 and the peel-away sheath 512 are advanced distallyover the flares 528 and the implant 304 until the distal tip of theimplant 304 is aligned with the distal end of the peel-away sheath 512and the distal end of the loading collar 510. The loading collar 510 canthen be removed resulting in the collapsed implant 304 located partiallywithin the recapture sheath 514 and retracted within the peel-awaysheath 512, and the entire system is flushed.

The implant 304 is inserted in the delivery sheath 504 and is advancedthrough the delivery sheath 504 by distal movement of the deliverycatheter 360. The implant 304 is aligned and positioned for deployment.Preferably, the implant 304 can maintain proper position by holding thedeployment handle 538 in a particular position. The delivery sheath 504can move proximally until the implant 304 is exposed. The surgeon canadjust the position of the implant 304 by collapsing the implant 304 andrepositioning the implant 304, and the repositioned implant 304 can bere-expanded. The implant 304 can be released from the delivery system500 after the implant 304 is properly positioned because recapture maynot be necessary. The delivery system 500 preferably is retracted andremoved through the delivery sheath 504. There are various techniques(e.g., contrast injections, fluoroscopy, thoracoscopy, and/orechocardiography) to confirm proper positioning and delivery of theimplant 304 and containment of thrombus within the LAA 502. The deliverysheath 504 preferably is withdrawn along the left atrium access path.

Thus, the delivery system 500 can be configured and sized to locate anddeploy the implant 304 in the LAA 502 as an adjunct to many surgicalprocedures which may or may not be related to the LAA 502. Depending onthe surgical procedure, one of the various embodiments of the deliverysystem 500 may be more conveniently used than other embodiments of thedelivery system 500 to deploy the implant 304.

In the illustrated embodiment of FIG. 41A, the implant 304 can bedelivered along a delivery path 910A that passes through an open leftatrium. A surgical procedure, such as open heart valve surgery, providesthe open left atrium for convenient access to the LAA 502. The surgicalprocedure can form an opening in the chest of a patient suitable foropen heart procedures. For example, the opening in the chest can beformed by a sternotomy incision. In one embodiment, the delivery path910A can be positioned by passing the distal end 702 of the deliverysheath 504 through the opening in the left atrium obtained for openheart surgery. The delivery sheath 504 in this embodiment may have alength of about 80 cm or less, about 70 cm or less, about 50 cm or less,about 30 cm or less, or even about 10 cm or less. In one embodiment, thedelivery sheath has a length of about 1 to 10 cm. As discussed above,the surgeon can easily manually position the delivery sheath 504. Thus,the delivery system 500 can be used to locate and deploy the implant 304to occlude the LAA 502. During open heart surgery, the delivery system500 can be used without the recapture sheath 514 because of theaccessibility of the LAA 502 and convenience of deploying the implant304. Those skilled in the art recognize that various catheters (e.g.,delivery sheath 504 and/or recapture sheath 514) can be used with thedelivery system 500. If the delivery sheath 504 is used during openheart surgery, the delivery sheath 504 is preferably generally straightand has a length less than the length of the delivery sheath 504 used,e.g., for implant 304 delivery through the femoral vein. Similarly, thelength of the delivery system 500 used for delivering the implant 304along the delivery path 910A is preferably less than the length of thedelivery system 500 used to deliver the implant 304 through the femoralvein.

In one embodiment, a deployment catheter 516A (shown in FIG. 43) is usedin conjunction with open heart surgery. In one embodiment, thedeployment catheter 516A is used without a delivery sheath. Thedeployment catheter 516A has the deployment handle 538 connected to ashaft 603. The implant 304 is located near a distal end 605 of the shaft603. The core 312 extends axially throughout the length of the shaft 603and can be attached at its distal end to the implant 304. The pull wireor control line 328 extends proximally throughout the length of theshaft 603 to the deployment handle 538. The shaft 603 can be sized andconfigured so that the implant 304 can be easily located and deployedwithin the LAA 502. In one embodiment, for example, shaft 603 has alength in the range of about 5 cm to 15 cm, more preferably in the rangeof about 9 cm to 11 cm. It will be appreciated that the shaft 603 mayhave any suitable length for access the LAA in an open procedure, suchas about 80 cm or less, about 70 cm or less, about 50 cm or less, orabout 30 cm or less. The shaft 603 can be a multi-lumen shaft, similarto the shaft 540 shown in FIG. 32A. The shaft 603 preferably comprisesthe core lumen 550 for holding the axially moveable core 312, thecontrol line lumen 552 and two proximal injection lumens 554 incommunication with proximal injection port 546. The control line 328preferably extends through the control line lumen 552 and preferablycouples to the proximal hub 324 of the implant 304 to the deploymenthandle control knob 542, allowing for implant 304 expansion andcollapse. Thus, during open heart surgery, for example, the implant 304can be passed directly into the left atrium of the open heart and alongthe delivery path 910A and into the LAA 502. Implant 304 is collapsed,preferably before it is passed through the left atrium and into the LAA502, by rotating the control knob 542 counterclockwise until the implant304 is fully collapsed. The counterclockwise motion of the control knob542 retracts at least a portion of the control line 328 and placestension on the proximal hub 324 of the implant 304. While the distalportion of the axially moveable core 312 engages slider assembly 400 andapplies a distal force to the distal hub 314 of the implant 304, tensionin the control line 328 preferably causes the proximal hub 324 of theimplant 304 to move proximally relative to the axially moveable core312, thereby collapsing the implant 304. In one embodiment, thedeployment catheter 516A comprises a multi-lumen shaft 603A (shown inFIGS. 44 and 45 without the control line 328) comprising the core lumen550 for holding the axially moveable core 312 and the control line lumen552. Although not illustrated, the deployment catheter 516A can be usedwith a delivery sheath 504 to aid in the delivery and deployment of theimplant 304.

As shown in FIG. 45, an insertion tool 538A comprises the shaft 603Aconnected to a handle 610 having a lever or trigger 612. The trigger 612can be moved towards the handle 610 thereby causing the implant 304 tocollapse. In one embodiment, the control line 328 is coupled to thetrigger 612 such that movement of the trigger 612 towards the handle 610retracts at least a portion of the control line 328, thereby placingtension on the proximal hub 324 of the implant 304. The tension in thecontrol line 328 causes the proximal hub 324 of the implant 304 to moveproximally relative to the axially moveable core 312, thereby collapsingthe implant 304. As tension on the pull wire 328 is reduced by movingthe trigger 612 away from the handle 610, the implant 304 assumes itsexpanded diameter configuration by bending under its own bias.Advantageously, the insertion tool 538A can facilitate proper placementof the implant 304, and the grip 310 can be shaped to conveniently fitthe hand of a user. In one embodiment, for example, shaft 603A has alength in the range of about 5 cm to 15 cm, more preferably in the rangeof about 9 cm to 11 cm, so that the implant 304 can be easily locatedand deployed in the LAA 502. Those skilled in the art recognize that thevarious catheters (e.g., delivery sheath 504 and/or recapture sheath514) can be used with the delivery system 500 shown in FIG. 45.

The implant 304 can also be manually deployed in the LAA 502, preferablyduring open heart surgery. Thus, the implant 304 can be positioned anddeployed within the LAA 502 without the use of a delivery system. Forexample, the surgeon can manually hold the implant 304 and pass theimplant 304 into the opened heart, through the left atrium, and into theLAA 502. The surgeon can manually apply an inward radial force to theframe 14 to collapse the implant 304 for convenient positioning at thedesired site. After the implant 304 is placed within the LAA 502, theimplant 304 can assume its expanded configuration by bending under itsown bias. Of course, to move the implant 304 into the LAA 502, thesurgeon can provide a distal force on the proximal hub 324 of theimplant 304 in the direction of the LAA 502. For example, because of theopen access to the left atrium during open heart surgery, the surgeon'sthumb can be conveniently used to push on the proximal hub 324 of theimplant 304 to move the implant 304 into the LAA 502, even though theimplant 304 engages with the wall of the LAA 502 because of the implant304 biasing to the expanded configuration. The surgeon can manuallyapply an inward radial force to the implant 304 to collapse the implant304 for convenient repositioning or removal of the implant 304.

As illustrated in the partial cross-sectional view of FIG. 46 and FIG.47, in another embodiment of a delivery system a delivery sheath 1002surrounds the implant 304 and a portion of a push rod 1010. The sheath1002 has a sheath wall 1003 defining an inner surface 1008 that engageswith the implant 304 to keep the implant 304 in the collapsed position.The push rod 1010 has a distal end 1012 that can contact the proximalhub 324 of implant 304. When the push rod 1010 is moved in the distaldirection the distal end 1012 contacts and causes the implant 304 tomove in the distal direction. Those skilled in the art recognize thatthe distal end 1012 may or may not be coupled to the proximal hub 324.When the implant 304 moves out of the sheath 1002, the implant 304 canexpand and assume its expanded diameter configuration by bending underits own bias. Preferably, the implant 304 is passed through the sheath1002 and deployed in the LAA 502 as an adjunct to open heart surgery.For example, during open heart surgery, the surgeon can hold and movethe proximal end 1013 of the push rod 1010 in the distal direction. Thepush rod 1010 and implant 304 move together in the distal directiontowards a distal end 1004 of the sheath 1002. As the implant 304 movesout of an opening 1005 of the sheath 1002, the implant 304 can expandunder its own bias. Preferably, the distal end 1004 of the sheath 1002is located proximate to the opening of the LAA 502 so that the implant304 expands within the LAA 502 upon exiting the sheath 1002. After theimplant 304 is expanded in the LAA 502, the sheath 1002 and the push rod1010 can be removed from the open heart. Of course, the surgeon canadjust the position of the implant 304 within the LAA 502. For example,as discussed above, the surgeon can manually provide a distal orproximal force on the proximal hub 324 to move the implant 304 relativeto the LAA 502.

To inhibit migration of the implant 304 out of the LAA 502, the implant304 can have barbs or anchors 195 that face proximally as describedabove. The anchors 195 can engage with adjacent tissue to retain theimplant 304 in its implanted position and can limit relative movementbetween the tissue and the implant 304. Further, after the implant 304is deployed, various techniques can be performed to ensure that theimplant 304 is properly located in the LAA 502. For example, the leftatrium or LAA may change shape or expand after the implant 304 isdeployed. The orifice of the LAA 502 can be sutured while the implant304 is within the LAA 502 to further fix the implant 304 into the LAA502.

It will be appreciated that the delivery systems for the implant 304described above can be used in combination with conventional instrumentsused in open surgical procedures or other procedures performed throughthe chest of a patient and any procedures that are being performed as anadjunct with the delivery of the implant 304 to the LAA. For example,when the implant is to be delivered through the chest, one embodiment ofthe invention includes a delivery sheath or catheter as described above,an implant sized and configured to prevent passage of embolic materialfrom the left atrial appendage, and means or instruments for providingsurgical access through the chest of the patient or for performingsurgical procedures on the heart, e.g., retractors, rib spreaders,forceps, scissors, shears, rongeurs, clip appliers, staplers, sutures,needle holders, bulldogs, clamps, elevators, cauterizing instruments orsubstances, electrosurgical pens, suction apparatus, approximators,and/or the like. When the implant is to be delivered through an outerwall of the left atrium, another embodiment of the invention includes adelivery sheath or catheter as described above, an implant sized andconfigured to prevent passage of embolic material from the left atrialappendage, and means or instruments for providing access through theleft atrium wall, e.g., trocars, port instruments, and the like. Whenthe implant is to be delivered as an adjunct to another surgicalprocedure, another embodiment of the invention includes a deliverysheath or catheter as described above, an implant sized and configuredto prevent passage of embolic material from the left atrial appendage,and means for performing surgical heart procedures, e.g., conventionalsurgical instruments (such as those described herein) for accessing theheart and performing surgical procedures on the heart. Thus,conventional surgical instruments can be used in conjunction with thedelivery of the implant, e.g., when the implant is delivered through theatrial wall of the heart, through the wall of LAA, etc.

Optionally, various procedures and instruments can be used inconjunction with the delivery of the implant, especially if the implantis delivered as an adjunct to an open surgical procedure or othersurgical heart procedure. For example, one or more verres needles,trocars, cannulas, insufflators, laparoscopes, light sources, videomonitors, forceps, scissors, clip appliers, sutures, needle holders,clamps, retractors, elevators, morcellators, cauterizing instruments orsubstances, electrosurgical cutting or grasping instruments, suctionapparatuses, approximators, and/or the like can be used before, during,and/or after the surgical procedures and/or delivery of the implant inthe LAA.

Throughout this application the terms implant and occlusion device havebeen used. One of ordinary skill in the art will appreciate that all ofthe disclosures herein are applicable to a wide variety of structuresthat include both implants that may or may not also be occlusiondevices. Routine experimentation will demonstrate those limitedcircumstances under which certain disclosures and combinations thereofare not beneficial.

Further details regarding left atrial appendages devices and relatedmethods are disclosed in U.S. Pat. No. 6,152,144, titled “Method andDevice for Left Atrial Appendage Occlusion,” filed Nov. 6, 1998, U.S.patent application Ser. No. 09/435,562, filed Nov. 8, 1999, U.S. patentapplication Ser. No. 10/033,371, titled “Adjustable Left AtrialAppendage Occlusion Device,” filed Oct. 19, 2001. The entirety of eachof these is hereby incorporated by reference in their entirety.

While particular forms of the invention have been described, it will beapparent that various modifications can be made without departing fromthe spirit and scope of the invention. Accordingly, it is not intendedthat the invention be limited, except as by the appended claims.

What is claimed is:
 1. A system for deploying a medical implant,comprising: a delivery catheter having a lumen extending therethrough;an elongate shaft slidably disposed within the lumen of the deliverycatheter; and an expandable implant including a proximal tubular portionand a distal tubular portion discontinuous with the proximal tubularportion; wherein the distal tubular portion extends at least partiallywithin an interior of the implant, wherein the distal tubular portionincludes a slot forming an opening extending from an interior surface ofthe distal tubular portion through a wall thereof to an exterior surfaceof the distal tubular portion.
 2. The system of claim 1, wherein theimplant is actuatable from a collapsed delivery configuration to anexpanded operational configuration.
 3. The system of claim 2, wherein adistal end of the elongate shaft extends through the proximal tubularportion and into the distal tubular portion in the collapsed deliveryconfiguration.
 4. The system of claim 3, further including a couplingmechanism configured to releasably couple the implant to the elongateshaft.
 5. The system of claim 4, wherein the implant is non-rotatablycoupled to the elongate shaft.
 6. The system of claim 3, furtherincluding a pull wire disposed within the lumen of the delivery sheathalongside the elongate shaft, the pull wire releasably connected to theproximal tubular portion by a releasable lock including a pin orientedlaterally through the proximal tubular portion.
 7. The system of claim6, wherein the pull wire includes first and second ends disposedadjacent a proximal end of the delivery sheath, and a portion of thepull wire extends over the pin to form a loop portion, the elongateshaft extending through the loop portion.
 8. The system of claim 7,wherein proximal tension on the pull wire with the elongate shaftdisposed within the distal tubular portion maintains the implant in thecollapsed delivery configuration.
 9. The system of claim 8, whereinaxial withdrawal of the distal end of the elongate shaft through theloop portion releases the pull wire from the proximal tubular portion.10. The system of claim 3, wherein the implant is self-biased toward theexpanded operational configuration.
 11. The system of claim 10, whereinthe elongate shaft has a column strength that exceeds an axial forceexerted on the distal end of the elongate shaft by a distal end of theimplant in the collapsed delivery configuration.
 12. The system of claim1, wherein the elongate shaft includes a lumen extending longitudinallytherethrough; and wherein the coupling mechanism includes a side portdisposed in a wall of the elongate shaft, a bending plug disposed withinthe elongate shaft adjacent the side port, and a locking member slidablydisposed within the lumen of the elongate shaft.
 13. The system of claim12, wherein the locking member extends axially within the lumen of theelongate shaft, through the side port, and through the slot, therebycoupling the implant to the elongate sheath.
 14. The system of claim 13,wherein axial retraction of the locking member through the slot and theside port releases the implant from the elongate shaft without relativerotation between the implant and the elongate shaft.
 15. The system ofclaim 1, further including a handle disposed on a proximal end of thedelivery catheter.
 16. The system of claim 15, wherein a proximal end ofthe elongate shaft is attached to a control element on the handle.